Recalls / Class II
Class IID-1080-2014
Product
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 55111-466, 55111-467
- FDA application
- ANDA090617
- Affected lot / code info
- Lot # C207420 and C207416
Why it was recalled
Failed Dissolution Specification; 12-Month stability interval.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 8,592 bottles
- Distribution pattern
- LA, MI, MO, MS & OH
Timeline
- Recall initiated
- 2013-12-13
- FDA classified
- 2014-02-06
- Posted by FDA
- 2014-02-12
- Terminated
- 2015-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1080-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.