Why it was recalled
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Product description
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Lot numbers, UPCs & expiration codes
Lot #: A102887, Exp. 6/2023
Where it was sold
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed 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-0899-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 27, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 3,096 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0899-2023, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 92618
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: A102887, Exp. 6/2023
- Postal code
- 21202-6174
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0899-2023
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 3,096 bottles
- Termination date
- Mar 12, 2024
- Reason for recall
- Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
- Distribution pattern
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
- Recall initiation date
- Jun 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2023