fda
7 records
FDA Drug Recall: DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit
2019-08-07
Class II — cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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FDA Drug Recall: Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Un
2019-07-17
Class II — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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FDA Drug Recall: Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose
2018-08-08
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton
2018-08-01
Class III — Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enal...
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FDA Drug Recall: Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmac
2018-08-01
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per cart
2018-08-01
Class III — Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enal...
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FDA Drug Recall: Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharma
2018-08-01
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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fda_adverse
2 records
FDA AE Manufacturer: Major Pharmaceuticals
Drug adverse event reporter — Product: DOCUSATE SODIUM
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FDA AE Manufacturer: MAJOR Pharmaceuticals Inc.
Drug adverse event reporter — Product: MAGNESIUM HYDROXIDE
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