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…
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate…
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate…
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate…
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…
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…
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…
Reason Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and…
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…
Reason Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia