Recalls / Class II
Class IID-1545-2020
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
- Affected lot / code info
- Batch # LOA19357A, exp. date 09/2021
Why it was recalled
Failed Tablet/Capsule Specification; complaint of bulging tablet
Recalling firm
- Firm
- Hetero Labs Limited (Unit V)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 458 Surv No 439 - 441, Polepally Village, Badepalle, N/A N/A, India
Distribution
- Quantity
- 43,512 bottles
- Distribution pattern
- Product was distributed to major wholesalers/distributors throughout the United States.
Timeline
- Recall initiated
- 2020-08-06
- FDA classified
- 2020-08-26
- Posted by FDA
- 2020-09-02
- Terminated
- 2022-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1545-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.