Why it was recalled
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Product description
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Lot numbers, UPCs & expiration codes
Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16
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-130-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 32,550 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-130-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63871
- Address
- 465 Industrial Way W
- Code information
- Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16
- Postal code
- 07724-2209
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-130-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 32,550 bottles
- Termination date
- Aug 4, 2014
- Reason for recall
- Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 7, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2013