Class I - Dangerous
Failed Impurities/Degradation Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Pacifico National, Inc.
Class I - Dangerous
Lack of assurance of sterility.
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class I - Dangerous
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Class I - Dangerous
Lack of Assurance of Sterility
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Compounded Solutions in Pharmacy
Class I - Dangerous
Lack of Processing Controls:
Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
American Health Packaging
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.