Drug product
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
D-1116-2019
Product summary
- Event
- Event 82585
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 121,668 bottles
- Official record key
drug-enforcement:D-1116-2019
Official wording
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Code information: Count, lots, expiry: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations