Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · last month
Allies Group Inc. THE ONE SPF 50 Invisible Sunscreen GEL, , 90ml - 3 fl. oz. Tube recall: Subpotent Product: Firm Testing indicated the affected product
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
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Class II · last month
Allies Group Inc. THE ONE SPF 50 Invisible Sunscreen GEL, , 3ml - 0.1 fl. oz recall: Subpotent Product: Firm Testing indicated the affected product
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
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Class I · last month
Baxter Healthcare Corporation 0.9% Sodium Chloride Injection USP 500 mL recall: Presence of particulate matter: Particulates identified as fiberglass
Presence of particulate matter: Particulates identified as fiberglass
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Class II · last month
Teva Pharmaceuticals USA, Inc traZODone Hydrochloride Tablets, USP, 50 mg recall: Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
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Class III · last month
American Health Packaging Buprenorphine Sublingual Tablets , 2 mg, 30 Tablets recall: Labeling: Label Mix-up
Labeling: Label Mix-up
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Class III · last month
Supernus Pharmaceuticals, Inc. Trokendi XR, extended-release capsules, 50 mg recall: Failed dissolution specifications
Failed dissolution specifications.
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Class II · last month
Baxter Healthcare Corporation Cardene IV in 0.83% Sodium Chloride Injection recall: CGMP Deviations
CGMP Deviations
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Class I · last month
Optimal Balance Pharmacy Glutathione 200 mg/mL, 30 mL sterile multidose vial recall: Microbial Contamination of Sterile Products - out of specifications results
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Class II · last month
Baxter Healthcare Corporation Daptomycin, in 0.9% Sodium Chloride Injection, 1 recall: CGMP Deviations
CGMP Deviations
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Class II · last month
Baxter Healthcare Corporation Vasopressin, in 0.9% Sodium Chloride Injection recall: CGMP Deviations
CGMP Deviations
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Class II · last month
Baxter Healthcare Corporation Clindamycin Injection USP in 5% Dextrose recall: CGMP Deviations
CGMP Deviations
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Class II · last month
Apotex Corp. Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle recall: Failed Dissolution Specifications; product failed to meet 24-month stability
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 112 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 88 mcg , 1000-count bottles recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 100 mcg recall: Subpotent Drug
Subpotent Drug
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Class I · last month
B Braun Medical Inc Lactated Ringer's Injection USP, 1000 mL EXCEL container recall: Presence of Particulate matter
Presence of Particulate matter.
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Class I · last month
Fresenius Kabi USA, LLC Tyenne Injection, 400 mg/20 mL , 20 mL vial recall: Presence of particulate matter:An internal investigation at the firm found
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 175 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Church & Dwight Co., Inc. Zicam, Cold Remedy, Medicated Nasal Swabs recall: CGMP Deviations; FDA inspection of the contract manufacturer noted
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 150 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Mallinckrodt Hospital Products Inc. Acthar Gel , 5 mL multiple-dose vial recall: Presence of particulate matter: glass and stopper piece
Presence of particulate matter: glass and stopper piece
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 75 mcg , 1000-count bottles recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 300 mcg , 90-count bottles recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Lupin Pharmaceuticals Inc. Clobetasol Propionate Cream USP, 0.05%, 60 g tube recall: Failed content uniformity specifications
Failed content uniformity specifications.