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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.

D-0114-2024

October 27, 2023

Class III

Product summary

Firm
NCS Healthcare of Kentucky Inc
Event
Event 93336
Status
Terminated
Classification
Class III
Quantity
12 cards
Official record key
drug-enforcement:D-0114-2024

Official wording

Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Code information: Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024

Distribution pattern: Nationwide USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets