Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 10 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle recall: CGMP Deviations: the presence of a nitrosamine impurity
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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Class II · 10 months ago
Lupin Pharmaceuticals Inc. Sertraline Hydrochloride Tablets USP, 100 mg recall: Defective container - seal not adhering to bottles
Defective container - seal not adhering to bottles
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Class II · 10 months ago
Lupin Pharmaceuticals Inc. Ganirelix Acetate Injection, 250 mcg/0.5mL recall: Failed impurities/degradation specifications: out of specification results
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
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Class III · 10 months ago
Winder Laboratories, LLC Morphine Sulfate Oral Solution 100 mg / 5 mL , 30 mL recall: Correct Labeled Product Mispack-Size stated on carton label did not match
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
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Class III · 10 months ago
Dr. Reddy's Laboratories, Inc. Varenicline Tablets, 1mg, 56 Tablets recall: Sub potent drug: during the 9-month stability test conducted
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
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Class II · 10 months ago
Cipla USA, Inc. Lanthanum Carbonate chewable tablets, 1000mg* recall: Failed stability specifications: Out of specification for hardness test
Failed stability specifications: Out of specification for hardness test
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Class II · 11 months ago
Blossom Pharmaceuticals WeCare, Zinc Oxide Ointment recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Dynagel, Moisturizing Wound Hydrogel recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Globe Clotrimazole Cream USP, 1 % Antifungal Cream recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Nivagen, Zinc Oxide Ointment recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Lanashield Skin Barrier, 4 oz recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Globe Clotrimazole Cream, USP, 1 % recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Cipla Limited Phytonadione Injectable Emulsion, USP 10mg/mL recall: Failed Stability Specifications: Observed OOS results: eg results for colour
Failed Stability Specifications: Observed OOS results: eg results for colour index
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Class II · 11 months ago
Blossom Pharmaceuticals Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % recall: cGMP deviations
cGMP deviations
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Class III · 11 months ago
Teva Pharmaceuticals USA, Inc Carton label: Testosterone Gel 1% recall: Defective Container - A defect in the side-seal which allows leakage
Defective Container - A defect in the side-seal which allows leakage of product.
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Class II · 11 months ago
Blossom Pharmaceuticals Dynashield, 4 oz cream , Manufactured for: Dynarex Corporation recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Class II · 11 months ago
Blossom Pharmaceuticals Wecare Calasoothe recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Wecare Enema, 4.5 Fl Oz/133mL recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Dynashield Skin Protectant recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Class II · 11 months ago
Park Avenue Compounding Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume recall: CGMP Deviations
CGMP Deviations
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Class II · 11 months ago
Blossom Pharmaceuticals Nivagen Pharmaceuticals, Zinc Oxide Ointment USP recall: cGMP deviations
cGMP deviations
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Class II · 11 months ago
Safecor Health, LLC Haloperidol Lactate Injection, 5 mg/mL recall: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.