Recalls / Class II
Class IID-1381-2014
Product
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
- 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 # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014
Why it was recalled
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
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, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 13560 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-23
- FDA classified
- 2014-06-12
- Posted by FDA
- 2014-06-18
- Terminated
- 2015-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1381-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.