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Recall Observatory FDA recall evidence

Drug product

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

D-0647-2025

August 27, 2025

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 97533
Status
Ongoing
Classification
Class II
Quantity
2,708 cartons
Official record key
drug-enforcement:D-0647-2025

Official wording

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Code information: Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance