Why it was recalled
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Product description
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Lot numbers, UPCs & expiration codes
Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
Where it was sold
Nationwide and Puerto Rico
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-132-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 30, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 43,478 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-132-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63967
- Address
- 465 Industrial Way W
- Code information
- Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
- Postal code
- 07724-2209
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-132-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 43,478 bottles
- Termination date
- Jul 9, 2014
- Reason for recall
- Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 30, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2013