Why it was recalled
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Product description
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
Lot numbers, UPCs & expiration codes
Lot #: DM12700, Exp 09/15
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-1346-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 1704 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1346-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71946
- Address
- 20 Waterview Blvd Ste 3
- Code information
- Lot #: DM12700, Exp 09/15
- Postal code
- 07054-1271
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1346-2015
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 1704 bottles
- Termination date
- Apr 12, 2017
- Reason for recall
- CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2015