Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product description
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
Lot numbers, UPCs & expiration codes
Batch number: H303487, H303488, H303489, Exp 09/16
Where it was sold
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
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-1502-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 6, 2016
- FDA report date
- Sep 28, 2016
- Quantity
- 20,556 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1502-2016, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 74945
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Batch number: H303487, H303488, H303489, Exp 09/16
- Postal code
- 21202-6174
- Report date
- Sep 28, 2016
- Product type
- Drugs
- Recall number
- D-1502-2016
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 20,556 bottles
- Termination date
- Aug 7, 2017
- Reason for recall
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
- Distribution pattern
- All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
- Recall initiation date
- Apr 6, 2016
- Initial firm notification
- Center classification date
- Sep 16, 2016