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

FDA recall notice · announced April 17, 2013 · Gsms

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Exp NDC Lot # Date 60429-046-10 69393A1 09/2015 60429-046-1 0 69395A1 09/2015 60429-046-10 69495A1 10/2015 60429-046-10 69496A1 10/2015 60429-046-01 69497A1 02/2014 60429-046-10 69524A1 10/2015 60429-046-10 69524A2 10/2015 60429-046-10 69525A1 10/2015 60429-046-10 69525A2 10/2015
Quantity: 6158 bottles
Status: Terminated
Products in this recall event:
- 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 (D-244-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.