Recalls / Class II
Class IID-0812-2021
Product
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
- Brand name
- Metoprolol Tartrate
- Generic name
- Metoprolol Tartrate
- Active ingredient
- Metoprolol Tartrate
- Route
- Oral
- NDCs
- 65862-062, 65862-063, 65862-064
- FDA application
- ANDA077739
- Affected lot / code info
- Lot: MJ1019025-A, Exp. date 04/2022
Why it was recalled
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 2,820 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-09-09
- FDA classified
- 2021-09-20
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0812-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.