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Recall Observatory FDA recall evidence

Drug product

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.

D-0113-2024

October 27, 2023

Class III

Product summary

Firm
NCS Healthcare of Kentucky Inc
Event
Event 93336
Status
Terminated
Classification
Class III
Quantity
1,344 cards
Official record key
drug-enforcement:D-0113-2024

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) 7718-3008, Exp 08/31/2024; b) 7718-3008, 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