Recalls / Class II
Class IID-1030-2020
Product
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
- Affected lot / code info
- Lot #: J0322819-091418, Exp: 09/30/2019
Why it was recalled
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 480 tablets
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2019-08-05
- FDA classified
- 2020-03-16
- Posted by FDA
- 2020-03-25
- Terminated
- 2023-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1030-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.