Presence of Particulate Matter: Due to production issues
Drugs Recalls
Prescription and over-the-counter medications
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
ANTHONY TRINH, 123Herbals
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.