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 · 4 months ago
CareFusion 213, LLC BD ChloraPrep CLear, and 70% v/v isopropyl alcohol) 100 x 10.5 mL 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
Asclemed USA Inc. Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 4 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 30 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
Lupin Pharmaceuticals Inc. Glucagon Emergency Kit for Low Blood Sugar recall: CGMP deviation: OOS result observed for the Gliding Force functionality test
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
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Class II · 4 months ago
CareFusion 213, LLC ChloraPrep Frepp, Clear, and 70% v/v isopropyl alcohol) 500 x 1.5 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 Fungal Fusion Eradication Solution, Antifungal & Antimicrobial Kit 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
CareFusion 213, LLC BD ChloraPrep Hi-Lite Orange, 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 Terpenicol Antifungal Solution, acid 25%), 1.0 Fl Oz 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 I · 4 months ago
CareFusion 213, LLC BD ChloraPrep FREPP Clear, and 70% v/v isopropyl alcohol ) 1.5 mL recall: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may…
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Class II · 4 months ago
Amgen, Inc. Sensipar Tablets, 30mg, 30-count bottles recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
Amgen, Inc. Sensipar Tablets, 90mg, 30-count bottles recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
Sun Pharmaceutical Industries Inc Perampanel CIII Tablets, 6mg recall: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
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Class III · 4 months ago
ANI Pharmaceuticals, Inc. hydrOXYzine Hydrochloride Oral Solution, USP recall: Presence of foreign substance
Presence of foreign substance
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Class I · 4 months ago
CareFusion 213, LLC BD ChloraPrep Clear and 70% v/v isopropyl alcohol ) recall: Non-Sterility: Due to presence of Aspergillus penicillioides
Non-Sterility: Due to presence of Aspergillus penicillioides.
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Class II · 4 months ago
PReye Vitamin See Antioxidant Preservative Free Eye Drops recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 4 months ago
The Harvard Drug Group LLC Carton Label: Major, Methylergonovine Maleate Tablets recall: Subpotent Drug
Subpotent Drug
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Class II · 4 months ago
Central Admixture Pharmacy Services, Inc. Total Parental Nutrition - Pediatric PN recall: Incorrect product formulation: bag did not contain copper and famotidine
Incorrect product formulation: bag did not contain copper and famotidine per label.
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep FREPP Clear, and 70% v/v isopropyl alcohol 1.5 mL recall: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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Class II · 4 months ago
Direct Rx Duloxetine D/R, a) 30 mg , 30 Caps recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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Class II · 4 months ago
Elevate Oral Care Povi-One, 10% Povidone-Iodine Oral Antiseptic recall: sub potency
sub potency
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Class II · 4 months ago
Amgen, Inc. Sensipar Tablets, 60mg, 30-count bottles recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
Ajanta Pharma USA Inc Fenofibrate Capsules, USP 200 mg recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
CareFusion 213, LLC BD ChloraPrep Clear, and 70% v/v isopropyl alcohol 1 mL Applicator recall: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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Class II · 4 months ago
Amgen, Inc. Corlanor tablets, 5 mg, packaged in a) 14 tablets bottles recall: Presence of Foreign Substance
Presence of Foreign Substance.