Drug product
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
D-1545-2020
Product summary
- Event
- Event 86191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,512 bottles
- Official record key
drug-enforcement:D-1545-2020
Official wording
Reason: Failed Tablet/Capsule Specification; complaint of bulging tablet
Code information: Batch # LOA19357A, exp. date 09/2021
Distribution pattern: Product was distributed to major wholesalers/distributors throughout the United States.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification; complaint of bulging tablet