Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 11 months ago
DermaRite Industries, LLC Lantiseptic, Dry Skin Therapy, Lanolin USP 30% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC Renew Skin Repair Cream, Dimethicone 1.5% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
Park Avenue Compounding Fentanyl citrate, 2 mcg / ml / Ropivacaine recall: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL)
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
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Class I · 11 months ago
Otsuka ICU Medical LLC Potassium Chloride Inj., 20 mEq total in 50 mL Flexible recall: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
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Class II · 11 months ago
DermaRite Industries, LLC Hand-E-Foam, Benzethonium Chloride 0.20% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC GelRite Instant Hand Sanitizer, Alcohol 65% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC UltraSure Anti-Perspirant & Deodorant recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class I · 11 months ago
Otsuka ICU Medical LLC Potassium Chloride Inj., 10 mEq total in 100 mL Flexible recall: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
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Class II · 11 months ago
DermaRite Industries, LLC San-E-Foam, Alcohol 67%, 1000 mL per cartridge recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
Golden State Medical Supply Inc. Niacin Extended-Release Tablets, USP, 1,000 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 11 months ago
DermaRite Industries, LLC Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC DermaMed Ointment, Skin Protectant recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC DermaSarra, Camphor 0.5%, External Analgesic recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC DermaFungal, Antifungal Cream with 2% Miconazole Nitrate recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 11 months ago
DermaRite Industries, LLC Lantiseptic, Skin Protectant, Lanolin USP 30% recall: CGMP Deviation; manufactured at the same facility where other products
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 75 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 50 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 25 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Aero Healthcare Acetaminophen 500mg Caffeine 65mg caplets recall: Labeling: Label Mix-up. This issue affects the outer box labeling only
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
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Class II · 12 months ago
Teva Pharmaceuticals USA, Inc Amoxicillin and Clavulanate Potassium for Oral recall: Subpotent drug; Clavulanate Potassium component
Subpotent drug; Clavulanate Potassium component