Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product description
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Lot numbers, UPCs & expiration codes
A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, Expiry: 2/29/2016.
Where it was sold
U.S. Nationwide including 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-1244-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2015
- FDA report date
- Jul 29, 2015
- Quantity
- A) 149,924 Bottles and B) 35,012 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1244-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71104
- Address
- 20 Waterview Blvd Ste 3
- Code information
- A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, Expiry: 2/29/2016.
- Postal code
- 07054-1271
- Report date
- Jul 29, 2015
- Product type
- Drugs
- Recall number
- D-1244-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- A) 149,924 Bottles and B) 35,012 Bottles
- Termination date
- May 9, 2018
- Reason for recall
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Apr 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2015