Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 12.5 g per 250 mL 250 mL in a 250 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fagron Compounding Services norepinephrine Bitartrate recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Clonidine Transdermal System, USP, 0.3 mg/day recall: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 2.5 g per 50 mL 50 mL in a 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Cipla USA, Inc. Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
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Class II · 6 months ago
GE Healthcare Ireland Limited GE Healthcare Omnipaque Injection, 350 mg/mL recall: Presence of particulate matter
Presence of particulate matter
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fagron Compounding Services Vancomycin HCI, 1.25 grams added to 250 mL recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Clonidine Transdermal System, USP, 0.1 mg/day recall: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL 500 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Clonidine Transdermal System, USP, 0.2 mg/day recall: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fagron Compounding Services Vancomycin HCI, 1.5 grams added to 250 mL recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Sterile EYE Drops Soothing Tears , 0.5 OZ 0.5 fl oz bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Sterile EYE DROPS AC , 0.5 fl. oz. bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc EYE DROPS Advanced Relief, , 0.5 FL OZ bottles, Sterile recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
Appco Pharma LLC Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle recall: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Sterile EYE Drops Redness Lubricant , 0.5 fl oz bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Dry Eye Relief Eye Drops, 0.5 FL OZ bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Sterile Eye Drops Original Formula , 0.5 FL OZ bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Ultra Lubricating Eye Drops , Sterile, 0.5 FL OZ bottles recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility