FDA recall D-1281-2015

Mutual Pharmaceutical Company, Inc. · Class II · drug

Product

Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.

Reason for recall

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Distribution

Nartionwide

Key facts

Status: Terminated
Initiation date: 2015-07-09
Report date: 2015-08-05
Termination date: 2016-10-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2015