Drug product
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
D-1104-2020
Product summary
- Event
- Event 85283
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 12,168; b) 17,196; c) 3,890
- Official record key
drug-enforcement:D-1104-2020
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: a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 2020
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations