Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Testosterone 200mg, Triamcinolone Acetonide 40mcg recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Estradiol, 10 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Testosterone, 87.5 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
Fresenius Kabi Compounding, LLC vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Estradiol, 25 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Testosterone, 25.0 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Testosterone, 200 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class II · 8 months ago
Amerisource Health Services LLC Oxycodone Hydrochloride Tablets, USP , 5 mg recall: Defective container: card seal defects (weak/non-existent seals)
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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Class II · 8 months ago
Fresenius Kabi Compounding, LLC ketamine HCl, 1,000 mg, 1 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 8 months ago
Fresenius Kabi Compounding, LLC thiamine HCl, 500 mg, 500 mg added to 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 8 months ago
Pro Numb Tattoo Numbing Spray, 5% Lidocaine recall: cGMP deviations
cGMP deviations
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Class II · 8 months ago
F.H. INVESTMENTS, Inc. Testosterone, 100 mg, 1 Sterile Pellet recall: Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
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Class I · 8 months ago
McKesson Udenyca, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled recall: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment…
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Class I · 9 months ago
Handelnine Global LLC Rheumacare capsules, 30 count bottle recall: CGMP Deviations: product found to contain lead
CGMP Deviations: product found to contain lead.
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Class II · 9 months ago
Sun Pharmaceutical Industries Inc Diclofenac Sodium, Topical Gel, 3%, 100 g tube recall: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
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Class II · 9 months ago
Granules Pharmaceuticals Inc. Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle recall: Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
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Class I · 9 months ago
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10 recall: Marketed without an Approved NDA/ANDA: FDA analysis found this product
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
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Class II · 9 months ago
Unichem Pharmaceuticals USA Inc. Bisoprolol Fumarate and Hydrochlorothiazide tablets recall: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
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Class II · 9 months ago
Sato Pharmaceutical Co., Ltd INON ACE Antacid tablets , 75-count bottle recall: Failed Disintegration Specifications: above the time expected
Failed Disintegration Specifications: above the time expected.
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Class II · 9 months ago
Greenstone Llc methylprednisolone tablets, USP Dosepak, 4 mg recall: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
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Class III · 9 months ago
Novadoz Pharmaceuticals LLC Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
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Class II · 9 months ago
Baxter Healthcare Corporation Sterile Water for Irrigation, 250 mL recall: Presence of particulate matter: plastic particles from the bottle rim
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
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Class III · 9 months ago
Haleon US Holdings LLC parodontax Active GUM Health, Mouthwash, Mint recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
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Class II · 9 months ago
Specialty Process Labs LLC Thyroid, USP recall: Subpotent Drug
Subpotent Drug