Class III · Low risk
candesartan cilexetil
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.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Class III · Low risk
Locoid (hydrocortisone butyrate 0.1%)
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Hydrocortisone Butyrate Cream 0.1%
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Amlodipine Besylate Tablets
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
Class II · Moderate risk
Hydromorphone Hydrochloride Injection
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 Mg/Ml
Crystallization: Formation of crystals observed in product.
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class II · Moderate risk
DOPamine Hydrochloride and 5% Dextrose INJ
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 12 month stability time point
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specification; at the 6-month stability time point
Class III · Low risk
BENZONATATE Capsules
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Class II · Moderate risk
Xarelto (rivaroxaban)
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Class II · Moderate risk
Assured Aspirin Enteric Safety Coated Tablets
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Class II · Moderate risk
TOPIRAMATE Tablets 200 mg
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Class II · Moderate risk
Tarceva (erlotinib)
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Class II · Moderate risk
Amiodarone HCl Injection
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Class III · Low risk
MethylPREDNISolone TABLETS
Subpotent; 6 month stability time point
Class I · High risk
Heparin Sodium
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.