FDA recall D-1702-2012

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

Reason for recall

Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

Distribution

The product was distributed to KY.

Key facts

Status
Terminated
Initiation date
2012-07-27
Report date
2012-10-03
Termination date
2013-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1702-2012