Why it was recalled
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Product description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
Lot numbers, UPCs & expiration codes
Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Where it was sold
Nationwide USA
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-0269-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2023
- FDA report date
- Feb 22, 2023
- Quantity
- (a) 6670 100-count (b) 2666 500-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0269-2023, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 91528
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
- Postal code
- 43217-1188
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0269-2023
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- (a) 6670 100-count (b) 2666 500-count bottles
- Termination date
- May 12, 2024
- Reason for recall
- Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jan 11, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2023