Drug product
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
D-1268-2019
Product summary
- Event
- Event 82661
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54,084 bottles
- Official record key
drug-enforcement:D-1268-2019
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] Lot BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063, BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp 11/30/2020; Lots BEF8E004, BEF8E005, exp 1/31/2021
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