1,739 recalls · Class I, newest first
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Reason Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Reason Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Reason Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Reason Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Reason Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Reason Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Reason Non-Sterility: failed sterility test result.
Reason Defective delivery system: detached needles on the syringe in the kit.
Reason Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Reason Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Reason Non Sterility; contaminated with Klebsiella pneumoniae
Reason Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Reason Non-Sterility; microbial contamination identified as Bacillus circulans
Reason Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Reason Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Reason Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Reason Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia