Skip to content
Recall Observatory FDA recall evidence

Drug product

chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15

D-0644-2025

August 25, 2025

Class II

Product summary

Firm
AvKARE
Event
Event 97548
Status
Ongoing
Classification
Class II
Quantity
2003 cartons
Official record key
drug-enforcement:D-0644-2025

Official wording

Reason: Presence of a foreign substance.

Code information: Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26

Distribution pattern: USA Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance