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Recall Observatory FDA recall evidence

Drug product

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

D-0461-2025

May 09, 2025

Class II

Product summary

Firm
AvKARE
Event
Event 96866
Status
Ongoing
Classification
Class II
Quantity
962 cartons
Official record key
drug-enforcement:D-0461-2025

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot # 47947, Exp 05/31/2026

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications