FDA recall D-66403-004

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01

Reason for recall

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-09-13
Report date
2013-11-13
Termination date
2015-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66403-004