Recalls / Class II
Class IID-1538-2022
Product
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
- Affected lot / code info
- Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Why it was recalled
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 1,699 blister cards/30 tablets each
- Distribution pattern
- Distributed to two direct accounts in PA and AK.
Timeline
- Recall initiated
- 2022-09-15
- FDA classified
- 2022-09-15
- Posted by FDA
- 2022-09-21
- Terminated
- 2022-11-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1538-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.