McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. Consumers who purchased product from […]
HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals – Recall
FDA notified healthcare professionals that Nurture, Inc., is recalling selected varieties and date codes of HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouch meals with date codes expiring between November 2010 and January 2011 due to a packaging defect that could cause a possible bacterial contamination. The meals are packaged in plastic […]
Rapamune (sirolimus): Drug Monitoring Recommendations
Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must […]
ev3 Endovascular Trailblazer Support Catheter
ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death. See the […]
Nzu, Traditional Remedy for Morning Sickness
The Texas Department of State Health Services and FDA notified healthcare professionals and consumers, especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to […]
Cordis CROSSOVER Sheath Introducer – Recall
Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids. The recall was due to stretching or fracture of the sheath during […]
Thermoflect Blankets and product line – Recall
Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels […]
Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer […]
Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels – Incorrect Packaging
Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot were printed with the label reversed. The label for the green Night product […]
Voltaren Gel (diclofenac sodium topical gel) 1 & #37; – Hepatic Effects Labeling Changes
Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month […]