Drug product
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
D-1455-2019
Product summary
- Event
- Event 83050
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,924,000 tablets
- Official record key
drug-enforcement:D-1455-2019
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 # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, 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