Recalls / Class II
Class IID-0009-2015
Product
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 0378-4595, 0378-4596, 0378-4597, 0378-4598
- FDA application
- ANDA202033
- Affected lot / code info
- Lot 3023805 Exp. 11/15
Why it was recalled
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 15,966 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-03
- FDA classified
- 2014-10-08
- Posted by FDA
- 2014-10-15
- Terminated
- 2016-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.