Why it was recalled
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Product description
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Lot numbers, UPCs & expiration codes
Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Where it was sold
Distributed to two direct accounts in PA and AK.
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-1538-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 1,699 blister cards/30 tablets each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1538-2022, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90873
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
- Postal code
- 15701-3571
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1538-2022
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 1,699 blister cards/30 tablets each
- Termination date
- Nov 16, 2022
- Reason for recall
- Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
- Distribution pattern
- Distributed to two direct accounts in PA and AK.
- Recall initiation date
- Sep 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2022