December 17, 2008Improper Use of Decorative Contacts May Haunt You Improper Use of Decorative Contacts May Haunt You
Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications. FDA Approves New Drug to Alleviate Moderate to Severe Pain The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? FDA Education Program Wins Award 'FDA Patient Safety News,' the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors. December 16, 2008FDA Approves Toviaz, a New Drug to Treat Overactive Bladder FDA Approves Toviaz, a New Drug to Treat Overactive Bladder
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. FDA Approves New Drug to Treat Severe Form of Epilepsy The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. Beware of Extortion Scam by FDA Impersonators As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials. HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated FDA Reports Significant Progress in Protecting the Food Supply The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain. FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. FDA Education Program Wins Award 'FDA Patient Safety News,' the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors. FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3) Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat. Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient (December 8) Balanced Health Products, Inc. has expanded its voluntarily recall of STARCAPS DIET SYSTEM DIETARY SUPPLEMENT to include additional Lot Numbers 12/2009 - 82866 and 12/2010 - 83801, sold in 30 capsule plastic bottles. FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures. Louisiana Fish Fry Products Issues Nationwide Allergy Alert on Undeclared Buttermilk in Chicken and Fish Bake Seasoned Coating Mix (December 5) The recalled Chicken and Fish Bake was distributed nationwide in retail stores and through mail orders. The product comes in a 6 ounce bag marked with a "Best By" date from Jan 1, 2008 thru Sept. 25, 2011. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination
Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets (November 7) ETHEX Corporation announced that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 (November 7) The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product. Louisiana Fish Fry Products Issues Nationwide Allergy Alert on Undeclared Buttermilk in Chicken and Fish Bake Seasoned Coating Mix (December 5) The recalled Chicken and Fish Bake was distributed nationwide in retail stores and through mail orders. The product comes in a 6 ounce bag marked with a "Best By" date from Jan 1, 2008 thru Sept. 25, 2011. Mexican Vanilla With Coumarin: No Bargain Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Fashion Sanctuary Issues a Voluntary Nationwide Recall of All Lots of Zhen De Shou Fat Loss Capsules Found to Contain an Undeclared Drug Ingredient (November 23) Fashion Sanctuary is recalling all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. Cambrooke Foods Voluntarily Recalls All Low Protein Imitation Cream Cheese Products Because of Possible Health Risk (December 12) Cambrooke Foods, LLC, of Framingham, MA, is announcing a voluntary recall of all batches of its Low Protein Imitation Cream Cheese ("Cheddar Wizard," "Herb and Garlic," and "Plain" flavors). December 15, 2008Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae (December 1) Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae (December 1)
Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes. FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp The U.S. Food and Drug Administration today announced the participants in Phase II of its pilot program for voluntary third-party certification programs for imported aquacultured shrimp. FDA Reports Significant Progress in Protecting the Food Supply The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain. Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 (November 7) The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish (December 12) The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product. Abbott says FDA OKs cholesterol drug TriLipix - Crain's Chicago Business Abbott says FDA OKs cholesterol drug TriLipix - Crain's Chicago Business
(AP) — Abbott Laboratories said Monday the Food and Drug Administration approved its cholesterol drug TriLipix for sale. TriLipix is part of a class of drugs called fibrates that raise "good" HDL cholesterol while reducing triglycerides and "bad Source: www.chicagobusiness.com Drug Trials Test Too Positive - San Francisco Gate Drug Trials Test Too Positive - San Francisco Gate
When drug companies seek approval to market new medicines, they must show the U.S. Food and Drug Administration the results of all the tests they've run on volunteer patients - at first on only a few, then on dozens, and finally on hundreds or Source: www.sfgate.com MDRNA, Inc. Announces Tentative FDA Approval of Generic Calcitonin - Market Wire BOTHELL, WA--(Marketwire - December 15, 2008) - MDRNA, Inc. ( NASDAQ : MRNA ) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA's Abbreviated New Drug Application (ANDA) for generic calcitonin Source: www.marketwire.com LegalView Alerts Readers of New Avandia Dangers for Women Taking the - Transworld News LegalView.com, the number one legal resource available on the Internet, recently reported updated news on the Avandia information portal describing the drug’s alleged increase of bone fractures among women using the type 2 diabetes drugs. According Source: www.transworldnews.com China Medicine to Distribute Dental and Surgical Instruments - Earthtimes GUANGZHOU, China , Dec. 15 /PRNewswire-Asia/ -- China Medicine Corporation (OTC Bulletin Board: CHME) ("China Medicine" or "the Company"), a leading developer and distributor of prescription and over the counter pharmaceuticals, traditional Chinese Source: www.earthtimes.org Boston Scientific's Express SD Renal Stent System Gets FDA Approval - RTT News (RTTNews) - Monday, biotechnology company, Boston Scientific Corp. (BSX: News ), said that the US Food and Drug Administration, or FDA, has approved its Express SD Renal Monorail Premounted Stent System as an adjunct to Percutaneous Transluminal Source: www.rttnews.com Bad pill to swallow - Petoskey News-Review We were a little taken aback to learn through an Associated Press investigation that hundreds — likely many hundreds — of drugs doctors prescribe every day have never been approved for our consumption by the U.S. Food and Drug Administration. To Source: www.petoskeynews.com FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt - WebWire The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., CAP-PELÈ, New Brunswick, Canada Source: www.webwire.com Stop and Shop Recalls Butternut Squash in Prepared Turkey and Ham Dinner (November 24) Stop and Shop Recalls Butternut Squash in Prepared Turkey and Ham Dinner (November 24)
Following a recall from its vendor, the Stop and Shop Supermarket Company has announced it is recalling all butternut squash sides that are packaged with the supermarket chain's prepared turkey and ham holiday dinners. Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae (December 1) Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes. FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish (December 12) The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product. December 14, 2008Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Web site for additional information Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Preventing Medical Errors: Recognizing Warfarin Brand Names A recent report by the Institute for Safe Medication Practices (ISMP) notes that some health professionals and patients may not realize that Jantoven is a brand name for the drug warfarin. That could result in inadvertently prescribing and dispensin... Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated FDA staff cites Acusphere drug risks, shares sink - Forbes FDA staff cites Acusphere drug risks, shares sink - Forbes
WASHINGTON (Reuters) - Safety risks with Acusphere (nasdaq: ACUS - news - people ) Inc's Imagify may be "inappropriate" for use in diagnosing patients with heart problems, Food and Drug Administration staff said in documents released Monday, sending Source: www.forbes.com Asthma Meds Under FDA’s Investigation - Eflux Media A Food and Drug Administration report concerning four drugs used to treat asthma said the products are linked with an increased risk of asthma-related side effects, esspecially where children are concerned. The analysis, released Friday, looked at Source: www.efluxmedia.com FDA nixes proposed ‘prescription pistol’ - Las Vegas Sun It could have been the world's first prescription pistol. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat. But Monday the Food and Drug Administration said Source: www.lasvegassun.com Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
See information in Related Information section. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC
The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Preventing Medical Errors: Drug Name Confusion: Ephedrine and Epinephrine The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of mix-ups between ephedrine and epinephrine. Not only do the names of these drugs look and sound similar, but since they're both used as vasopressors and vaso... HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. (Update) FDA Concerned About Asthma Drug Risks For Kids - dbtechno.com (Update) FDA Concerned About Asthma Drug Risks For Kids - dbtechno.com
Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) is very concerned about the risks associated with certain asthma drugs, as they have been found to increase the risks of asthma-related deaths and asthma attacks for those who take Source: www.dbtechno.com TOPIC | Obstetrics and Gynecology - Daily Oklahoman Hormone use, risk of cancer linked 2 hr ago | Add a comment SAN ANTONIO — Taking menopause hormones for five years doubles the risk for breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of Source: newsok.com FDA Panel Rules: Two Popular Asthma Drugs Risky, Advair and Symbicort - Eflux Media A Food and Drug Administration panel said Thursday that the risk of taking the asthma medications Serevent and Foradil generally outweighs the benefits of the drugs when they are not prescribed along with steroids. Serevent is a combination of an Source: www.efluxmedia.com ERBITUX® Supplemental Biologics License Application for Advanced Non - MSN MoneyCentral ImClone Systems , a wholly-owned subsidiary of Eli Lilly and Company LLY , and Bristol-Myers Squibb Company BMY today announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX Source: news.moneycentral.msn.com Tesetaxel, Leading Oral Taxane In Clinical Development, Receives FDA - Medical News Today Genta Incorporated (OTCBB: GNTA) announced today that the Company has received notice from the U.S. Food and Drug Administration (FDA) that tesetaxel, the Company's oral taxane in clinical development, has been granted designation as an "Orphan Drug Source: www.medicalnewstoday.com Innohep (tinzaparin sodium injection) Innohep (tinzaparin sodium injection)
Clinical study stopped early because of interim finding of increase in all-cause mortality in patients who received Innohep. Nestle USA Voluntarily Recalls Two Production Codes of Nestle Nesquik Strawberry Powder (November 7) The recall only includes two (2) production codes of 21.8-ounce containers of Nestle Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010." Limited Recall of LAND O LAKES Sheep Balancer B136 (December 4) The Land O'Lakes Purina Feed plant in Lincoln, Neb., has initiated a limited recall of LAND O LAKES Sheep Balancer B136, packaged in 50-pound bags, due to the potential for a higher than acceptable level of copper. The recall is limited to Sheep Balancer B136 produced at the Lincoln plant on October 8, 2008. Recalls and Safety Alerts: Filter Ammonul to Remove Particulates Ucyclyd Pharma is notifying healthcare professionals that particulate matter has been detected in Ammonul Injection. Ammonul is used as an adjunct in treating hyperammonemia in certain patients with urea cycle disorders. The company says that the... Recalls and Safety Alerts: Problems with Medtronic Intrathecal Catheters Medtronic has alerted healthcare professionals about the potential for misconnections between certain sutureless intrathecal catheters and the implanted infusion pumps to which they're attached. The four affected products are: ? INDURA 1P Intrath... Recalls and Safety Alerts: Hepatic Failure and Hepatorenal Syndrome with Tarceva OSI Pharmaceuticals and Genentech are alerting healthcare professionals about hepatic failure and hepatorenal syndrome with the use of Tarceva (erlotinib), particularly in patient with baseline hepatic impairment. Tarceva is approved to treat certai... |
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