Drug Enforcement D-0647-2025

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.

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
2,708 cartons
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0647-2025
Event ID
97533
Recall initiation date
August 27, 2025
Center classification date
September 15, 2025
Code info
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
More code info
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