Why it was recalled
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Product description
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Lot numbers, UPCs & expiration codes
Lot: MJ1019025-A, Exp. date 04/2022
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-0812-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 9, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 2,820 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0812-2021, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88639
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot: MJ1019025-A, Exp. date 04/2022
- Postal code
- 08520-1401
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0812-2021
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 2,820 bottles
- Termination date
- Oct 31, 2023
- Reason for recall
- Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2021