Prescription & OTC drugs recalls
Every prescription & otc drugs recall on file, newest first, each one linked back to the federal notice it came from.
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Class II · 3 months ago
Onesource Specialty Pharma Limited Methohexital Sodium for Injection recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
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Class II · 4 months ago
Boehringer Ingelheim Pharmaceuticals, Inc. Synjardy XR Tablets , 12.5/1000 mg recall: CGMP Deviations: An incorrect detergent was used and the required swab
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
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Class II · 4 months ago
Lannett Company Inc. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate recall: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Clear, , and 70% v/v isopropyl alcohol recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Hi-Lite Orange recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Scrub Teal, and 70% v/v isopropyl alcohol) packaged recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
McKesson Gemcitabine Injection, 1 g per 26.3 mL , 26.3 mL Single-Dose Vial recall: Temperature Abuse: Product was stored incorrectly in a controlled room
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Hi-Lite Orange recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
Blaine Labs Inc Terpenicol Antifungal Cream , 1.0 oz bottles recall: CGMP Deviations; the firm discontinued required stability testing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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Class II · 4 months ago
Blaine Labs Inc Trifluent Pharma Tridergel Wound Care Gel, , 1.0 fl oz recall: CGMP Deviations: product manufactured in the same facility under the same
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
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Class II · 4 months ago
Accord Biopharma Inc Imuldosa, Injection, 130 mg/26 mL recall: Lack of assurance of Sterility
Lack of assurance of Sterility:
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Class II · 4 months ago
Asclemed USA Inc. Lidocaine HCl Injection USP, 1% , 5 mL single dose ampule recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 4 months ago
Blaine Labs Inc vite20 Antifungal Cream, , 0.54 OZ bottle recall: CGMP Deviations; the firm discontinued required stability testing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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Class II · 4 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle recall: cGMP Deviations: presence of N-nitroso-cinacalcet
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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Class II · 4 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle recall: cGMP Deviations: presence of N-nitroso-cinacalcet
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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Class II · 4 months ago
CareFusion 213, LLC BD PurPrep, with isopropyl alcohol 72.5% w/w) recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 300 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Scrub Teal, and 70% v/v isopropyl alcohol) packaged recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
Blaine Labs Inc Revitaderm Wound Care, First Aid Antiseptic Gel recall: CGMP Deviations; product manufactured in the same facility under the same
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
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Class II · 4 months ago
Lupin Pharmaceuticals Inc. prednisoLONE Acetate Ophthalmic Suspension, USP, 1% recall: Presence of Foreign Substance
Presence of Foreign Substance
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep CLear, and 70% v/v isopropyl alcohol) recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
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Class II · 4 months ago
Blaine Labs Inc Tripenicol S Antifungal Solution , 1.25 FL OZ bottle recall: CGMP Deviations; the firm discontinued required stability testing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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Class III · 4 months ago
Sun Pharmaceutical Industries Inc Fexofenadine Hydrochloride Tablets recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
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Class I · 4 months ago
Blaine Labs Inc Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1% recall: Microbial contamination of Non-Sterile Product: samples identified
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp