Status
Terminated
Drug Enforcement D-244-2013
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Classification
Class II
Report Date
April 17, 2013
Termination Date
September 3, 2013
Product Information
- Product description
- 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
- Product quantity
- 6158 bottles
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Gsms
- Address
-
5187 Camino Ruiz
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-244-2013
- Event ID
- 64695
- Recall initiation date
- March 11, 2013
- Center classification date
- April 7, 2013
- Code info
- 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
- More code info
- —