Drug product
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
D-1456-2019
Product summary
- Event
- Event 83050
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,943,000 tablets
- Official record key
drug-enforcement:D-1456-2019
Official wording
Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Code information: Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
Distribution pattern: Nationwide by 4 major distributors.
Derived failure modes
-
Foreign material or chemical contamination
impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations