FDA recall D-1424-2015

Mutual Pharmaceutical Company, Inc. · Class III · drug

Product

Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01

Reason for recall

Chemical Contamination; benzophenone leached from the product label varnish

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-07-16
Report date
2015-09-16
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-1424-2015