September 25, 2008
 

FDA Drug Safety Newsletter


FDA Drug Safety Newsletter
Summer 2008 edition available for healthcare professionals and the medical community.

Phosphocol P 32 (Chromic Phosphate P 32 Suspension)
Risk of leukemia associated with off-label intra-articular use in children.

Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14)
Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor.

Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
See Web site for additional information.

Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
See additional information in Related Information section.

Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label.

Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16)
Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product.

Infant Formula Manufactured in China Contaminated With Melamine
UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves.

LifePak CR Plus Automated External Defibrillators
Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy.

Tarceva (erlotinib)
Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.

# posted by Network @ 12:00 AM

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