Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and…
Reason Subpotent Drug
FDA Drug Recalls
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Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl…
Reason Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class III · Low risk Ongoing
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan…
Reason Presence of precipitate
Class I · High risk Ongoing
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na…
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class III · Low risk Ongoing
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Class III · Low risk Ongoing
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk Ongoing
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton…
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…
Reason Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Class II · Moderate risk Ongoing
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD…
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk Ongoing
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC…
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk Ongoing
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL…
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk Ongoing
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1…
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).