Class III · Low risk Terminated
Simvastatin Tablets
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Simvastatin Tablets
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk Terminated
Simvastatin Tablets
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk Terminated
Eye Drops Advanced Relief
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops Industrial Strength
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops A.C.
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Dacarbazine
Reason Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Class III · Low risk Terminated
Mucinex DM
Reason Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Class III · Low risk Terminated
Sterile powder Vancomycin Hydrochloride for Injection
Reason Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Class III · Low risk Terminated
Scrub Care Chlorhexidine Gluconate Solution
Reason Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Class III · Low risk Terminated
Carbamazepine Tablets USP
Reason Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Class III · Low risk Terminated
Z-Cote Hp 1 Transparent Zinc Oxide
Reason cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk Terminated
TORISEL Kit
Reason Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Class III · Low risk Terminated
MethylPREDNISolone Tablets
Reason Subpotent; 6 month stability time point
Class III · Low risk Terminated
candesartan cilexetil
Reason Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Class III · Low risk Terminated
Locoid
Reason Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk Terminated
Hydrocortisone Butyrate Cream 0.1%
Reason Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk Terminated
Amlodipine Besylate Tablets
Reason Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Class III · Low risk Terminated
Truvada
Reason Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class III · Low risk Terminated
BENZONATATE Capsules
Reason Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.