FDA recall D-244-2013

Gsms · Class II · drug

Product

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA

Reason for recall

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-03-11
Report date: 2013-04-17
Termination date: 2013-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-244-2013