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Amerisource Health Services LLC: Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Amerisource Health Services LLC
Product
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
Reason / hazard
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-10-16
Code info
Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
Product quantity
1,818 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Columbus
State
OH
Country
United States
Event id
97826
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