D-1545-2020 Class II Terminated
FDA drug recall D-1545-2020 was initiated by Hetero Labs Limited (Unit V) on August 6, 2020 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specification; complaint of bulging tablet The recall status is terminated (terminated January 24, 2022). Affected quantity: 43,512 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- August 6, 2020
- Termination Date
- January 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,512 bottles
Product Description
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Reason for Recall
Failed Tablet/Capsule Specification; complaint of bulging tablet
Distribution Pattern
Product was distributed to major wholesalers/distributors throughout the United States.
Code Information
Batch # LOA19357A, exp. date 09/2021