Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 5 months ago
Spectra Medical Devices, Llc Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 5 months ago
Guardian Drug Co. Inc. Haleon Calcium Carbonate Tums Antacid, Assorted Fruit Tablets recall: Presence of foreign substance: small metallic particles in chewable tablets
Presence of foreign substance: small metallic particles in chewable tablets.
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Class III · 5 months ago
AbbVie Inc. Pred Mild, prednisolone acetate ophthalmic suspension, USP, 0.12% recall: Failed Stability Specifications
Failed Stability Specifications
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Class III · 5 months ago
AVEVA Drug Delivery Systems, Inc. Nicotine Transdermal System Patch, 14 mg recall: Failed Impurities/Degradation Specifications: Elevated levels
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
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Class II · 5 months ago
Safecor Health, LLC Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral recall: Presence of a Foreign Substance; black particles observed in liquid
Presence of a Foreign Substance; black particles observed in liquid
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Class II · 5 months ago
Haleon US Holdings LLC Gas-X, Simethicone 125 mg/ Antigas, 120 SoftGels recall: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
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Class III · 5 months ago
Lannett Company Inc. Primidone Tablets USP, 250mg, 100-count bottle recall: Cross contamination with other products: API contaminated with trace amounts
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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Class III · 5 months ago
Sagent Pharmaceuticals Busulfan Injection, 60 mg per 10 mL , 8x10 mL Single-Dose Vials recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
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Class II · 5 months ago
ANI Pharmaceuticals, Inc. Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet recall: Defective Container; packets were found to be either empty or partially full
Defective Container; packets were found to be either empty or partially full.
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Class III · 5 months ago
Amerisource Health Services LLC Primidone Tablets, USP, 250 mg, 100 Tablets per carton recall: Cross contamination with other products: API contaminated with trace amounts
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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Class II · 5 months ago
UCB Biosciences Inc. cimzia , 2x200mg/mL Prefilled Syringes recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class I · 5 months ago
Wisconsin Pharmacal Company MG217 Multi-Symptom Treatment Cream & Skin Protectant recall: Microbial Contamination of Non-Sterile Products: confirmed presence
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
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Class III · 5 months ago
Golden State Medical Supply Inc. Primidone Tablets, USP, 250 mg, 100-count bottle recall: Cross contamination with other products: API contaminated with trace amounts
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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Class III · 5 months ago
Golden State Medical Supply Inc. Primidone Tablets, USP, 50 mg, 50-count bottle recall: Cross contamination with other products: API contaminated with trace amounts
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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Class III · 5 months ago
Amerisource Health Services LLC Primidone Tablets, USP, 50 mg, 100 Tablets per carton recall: Cross contamination with other products: API contaminated with trace amounts
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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Class II · 5 months ago
Zydus Pharmaceuticals Inc Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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Class II · 5 months ago
Lupin Pharmaceuticals Inc. Liraglutide Injection, 18 mg/3 mL recall: Presence of particulate matter: a white thread-like structure in the cartridge
Presence of particulate matter: a white thread-like structure in the cartridge
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Class II · 5 months ago
Zydus Pharmaceuticals Inc Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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Class II · 5 months ago
IntegraDose Compounding Services LLC fentaNYL Citrate, Sterile CADD for Injection, 2 recall: Subpotent Drug
Subpotent Drug
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Class II · 5 months ago
Safecor Health, LLC Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
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Class II · 5 months ago
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 5 months ago
ENDO USA, Inc. Buprenorphine Hydrochloride, Injection, 0.3mg/mL recall: Crystallization; identified as Buprenorphine free base
Crystallization; identified as Buprenorphine free base
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Class II · 5 months ago
Oasis Tears PF, Preservative-Free Lubricant Eye Drops recall: Lack of Assurance of Sterility: The recall is being initiated
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 60 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…