Recalls / Class II
Class IID-1702-2012
Product
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
- Brand name
- Levetiracetam
- Generic name
- Levetiracetam
- Active ingredient
- Levetiracetam
- Route
- Oral
- NDCs
- 0378-5615, 0378-5617, 0378-5619
- FDA application
- ANDA076919
- Affected lot / code info
- Lot ZLMM12063, Exp March 2014
Why it was recalled
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 960 bottles
- Distribution pattern
- The product was distributed to KY.
Timeline
- Recall initiated
- 2012-07-27
- FDA classified
- 2012-09-27
- Posted by FDA
- 2012-10-03
- Terminated
- 2013-05-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1702-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.