Why it was recalled
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Product description
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Lot numbers, UPCs & expiration codes
Lot #: H800414, Exp. 12/2019
Where it was sold
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
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-1077-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 11,706 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1077-2018, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80789
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: H800414, Exp. 12/2019
- Postal code
- 21202-6174
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1077-2018
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 11,706 bottles
- Termination date
- Oct 15, 2019
- Reason for recall
- Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
- Distribution pattern
- Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
- Recall initiation date
- Aug 13, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2018