Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Pacific Compounding Pharmacy & Consultations
Class I - Dangerous
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Class I - Dangerous
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class I - Dangerous
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class I - Dangerous
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class I - Dangerous
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
Ata International
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Ingenus Pharmaceuticals
Class I - Dangerous
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class I - Dangerous
cGMP Deviations
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class I - Dangerous
Defective Container: Repetitive complaints received indicating pump not working.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Iso-Tex Diagnostics
Class I - Dangerous
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class I - Dangerous
Lack of Assurance of Sterility
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
Rx Pak Division of McKesson
Class I - Dangerous
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.