Why it was recalled
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Product description
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
Lot numbers, UPCs & expiration codes
Lot # Q900683, Exp. 10/31/2022
Where it was sold
Nationwide within the US.
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-1290-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 4,224 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1290-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85770
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # Q900683, Exp. 10/31/2022
- Postal code
- 21202-6174
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1290-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4,224 bottles
- Termination date
- May 4, 2021
- Reason for recall
- Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
- Distribution pattern
- Nationwide within the US.
- Recall initiation date
- May 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2020