Why it was recalled
Failed Dissolution Specifications
Product description
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
Lot numbers, UPCs & expiration codes
Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023
Where it was sold
Nationwide in the 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-0451-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 6,637 500-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0451-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 89377
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023
- Postal code
- 43217-1188
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0451-2022
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 6,637 500-count bottles
- Termination date
- Mar 9, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 20, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2022