Recall archive
5 recalls · page 1 of 1
Reported Dec 6, 2023
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bayer Healthcare Pharmaceuticals Inc.
Matched: Brand · Product · Product details — Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing…
FDA (openFDA drug enforcement)
Reported Nov 24, 2021
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer Healthcare Pharmaceuticals Inc.
Matched: Brand · Product · Product details — cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
18 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 24, 2013
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Bayer HealthCare Pharmaceuticals Inc.
Matched: Brand · Product · Product details — Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
FDA (openFDA drug enforcement)
Reported Feb 13, 2013
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Bayer HealthCare Pharmaceuticals Inc.
Matched: Brand · Product · Product details — Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
FDA (openFDA drug enforcement)
Reported Aug 8, 2012
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bayer HealthCare Pharmaceuticals Inc.
Matched: Brand · Product details · Reason for recall — Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
FDA (openFDA drug enforcement)
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