Recalls / Class II
Class IID-0727-2018
Product
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 55111-468, 55111-469
- FDA application
- ANDA078889
- Affected lot / code info
- Batch # C706254, 08/2019
Why it was recalled
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
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
- 8160 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-04-23
- FDA classified
- 2018-05-09
- Posted by FDA
- 2018-05-16
- Terminated
- 2020-12-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0727-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.