Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 7 months ago
K.C. Pharmaceuticals, Inc Artificial Tears Sterile Lubricant Eye Drops recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class I · 7 months ago
Amneal Pharmaceuticals, LLC Magnesium Sulfate in Water for Injection, 4g/100 mL IV bag recall: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
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Class II · 7 months ago
Appco Pharma LLC Prazosin Hydrochloride Capsules, USP, 2mg, 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
Amneal Pharmaceuticals, LLC traMADol Hydrochloride Tablets, USP, 50 mg recall: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
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Class II · 7 months ago
Appco Pharma LLC Prazosin Hydrochloride Capsules, USP, 1mg, 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
Chiesi USA, Inc. Curosurf , 240 mg, Intratracheal Suspension, 3L Single-dose-Vial recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 7 months ago
Radnostix Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit recall: Failed Tablet/Capsule Specifications
Failed Tablet/Capsule Specifications
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Class II · 7 months ago
Amerisource Health Services LLC Meclizine Hydrochloride Tablets, USP 12.5 mg recall: Failed tablet specifications
Failed tablet specifications.
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Class II · 7 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 7 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 7 months ago
Macleods Pharma USA, Inc Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle recall: Subpotent Drug
Subpotent Drug
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Class II · 7 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 7 months ago
Somerset Therapeutics LLC Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL recall: Failed Impurities/Degradation Specifications - OOS impurities result observed
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were…
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Class I · 7 months ago
Cardinal Health 200, LLC Webcol Alcohol Prep pad 2 ply, 200 count boxes recall: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
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Class III · 7 months ago
Annora Pharma Private Limited Pitavastatin Tablets, 2 mg, packaged in 90-count bottles recall: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
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Class II · 7 months ago
Strides Pharma Inc Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL recall: Presence of foreign substance: the firm received complaints for a gel-like
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
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Class II · 7 months ago
Apotex Corp. Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 7 months ago
Zydus Pharmaceuticals Inc Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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Class I · 8 months ago
ANTHONY TRINH, 123Herbals LLC Silintan 25/pills, packaged in a 25-count bottle recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
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Class II · 8 months ago
Acme United Corporation Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Teva Pharmaceuticals USA, Inc Metoprolol Succinate Extended-Release Tablets recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 8 months ago
Acme United Corporation 1) BZK Antiseptic Towelettes 5"x7" Piedmont Sanitizing Hand recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Acme United Corporation WP WipesPlus Hand Sanitizing Wipes , 5x7, 100 CT recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Acme United Corporation Cleansing Towelette , 5"x 7", 1,000 case/Bulk recall: CGMP Deviations
CGMP Deviations