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chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, D...

FDA Recall #D-0649-2025 — Class II — August 27, 2025

Recall #D-0649-2025 Date: August 27, 2025 Classification: Class II Status: Ongoing

Product Description

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)

Reason for Recall

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.

Recalling Firm

Amerisource Health Services LLC — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1,757 cartons

Distribution

Nationwide in the USA

Code Information

Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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