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Recall Observatory FDA recall evidence

Drug 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).

D-1030-2020

August 05, 2019

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 83645
Status
Terminated
Classification
Class II
Quantity
480 tablets
Official record key
drug-enforcement:D-1030-2020

Official wording

Reason: 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.

Code information: Lot #: J0322819-091418, Exp: 09/30/2019

Distribution pattern: PA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets