Why it was recalled
Labeling: Label-mixup
Product description
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
Lot numbers, UPCs & expiration codes
Lot #: 1905005661, Exp March 2022
Where it was sold
Nationwide within 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-0326-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 17, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- 12288 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0326-2021, exactly as published.
Show all FDA fields
- City
- Tajpura
- Status
- Terminated
- Country
- India
- Event ID
- 87533
- Address
- Near Baska
- Code information
- Lot #: 1905005661, Exp March 2022
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0326-2021
- Classification
- Class I
- Recalling firm
- Alembic Pharmaceuticals Limited
- Product quantity
- 12288 bottles
- Termination date
- Dec 5, 2022
- Reason for recall
- Labeling: Label-mixup
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2021