Why it was recalled
Failed Tablet/Capsule Specification; complaint of bulging tablet
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
Lot numbers, UPCs & expiration codes
Batch # LOA19357A, exp. date 09/2021
Where it was sold
Product was distributed to major wholesalers/distributors throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1545-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 43,512 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited (Unit V)
Original FDA data
Every field from FDA enforcement report D-1545-2020, exactly as published.
Show all FDA fields
- City
- Badepalle
- Status
- Terminated
- Country
- India
- Event ID
- 86191
- Address
- 458 Surv No 439 - 441
- Address (line 2)
- Polepally Village
- Code information
- Batch # LOA19357A, exp. date 09/2021
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1545-2020
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited (Unit V)
- Product quantity
- 43,512 bottles
- Termination date
- Jan 24, 2022
- Reason for recall
- Failed Tablet/Capsule Specification; complaint of bulging tablet
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to major wholesalers/distributors throughout the United States.
- Recall initiation date
- Aug 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2020