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Recall Observatory FDA recall evidence

Drug product

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

D-0643-2025

August 25, 2025

Class II

Product summary

Firm
AvKARE
Event
Event 97548
Status
Ongoing
Classification
Class II
Quantity
1512 cartons
Official record key
drug-enforcement:D-0643-2025

Official wording

Reason: Presence of a foreign substance.

Code information: Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25

Distribution pattern: USA Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance