Why it was recalled
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-244-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2013
- FDA report date
- Apr 17, 2013
- Quantity
- 6158 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gsms
Original FDA data
Every field from FDA enforcement report D-244-2013, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64695
- Address
- 5187 Camino Ruiz
- 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
- Postal code
- 93012-8601
- Report date
- Apr 17, 2013
- Product type
- Drugs
- Recall number
- D-244-2013
- Classification
- Class II
- Recalling firm
- Gsms
- Product quantity
- 6158 bottles
- Termination date
- Sep 3, 2013
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2013