FDA recall D-1703-2012

Mylan Pharmaceuticals Inc. · Class III · drug

Product

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

Reason for recall

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Distribution

Nationwide and PR

Key facts

Status
Terminated
Initiation date
2012-06-28
Report date
2012-10-10
Termination date
2013-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1703-2012