Lack of Assurance of Sterility
Drugs Recalls
Prescription and over-the-counter medications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Efficient Laboratories
Microbial Contamination of Non-Sterile Products
Subpotent
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
The Harvard Drug Group
Failed Impurities/Degradation Specifications
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Denver Solutions, LLC
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
Efficient Laboratories
Microbial Contamination of Non-Sterile Products
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06
Efficient Laboratories
Microbial Contamination of Non-Sterile Products