Class II · Moderate risk
AMGEN Kyprolis
Lack of Assurance of Sterility: Potential cracks in glass vials
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
Class II · Moderate risk
Rabeprazole Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class III · Low risk
VirtPrex Prenatal/Postnatal Tablets
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Select Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Extra-Virt Plus DHA Prenatal/Postnatal Softgel
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Advance Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class I · High risk
SLIMFIT X capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class II · Moderate risk
10% Premasol sulfite-free
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Class III · Low risk
INOVA (benzoyl peroxide)
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class III · Low risk
Endure 400 Scrub-Stat
Subpotent Drug
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications
Class I · High risk
MegaJex Herbal Supplement
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)
Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class III · Low risk
Protonix I.V.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class III · Low risk
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick
Labeling: Label Mix Up- Incorrect back label applied to the product.
Class II · Moderate risk
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
CGMP Deviations
Class II · Moderate risk
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
CGMP Deviations