Status
Terminated
Drug Enforcement D-1702-2012
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Classification
Class II
Report Date
October 3, 2012
Termination Date
May 21, 2013
Product Information
- Product description
- Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
- Product quantity
- 960 bottles
- Reason for recall
- Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- The product was distributed to KY.
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Address
-
781 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1702-2012
- Event ID
- 62885
- Recall initiation date
- July 27, 2012
- Center classification date
- September 27, 2012
- Code info
- Lot ZLMM12063, Exp March 2014
- More code info
- —