Recalls / Class III

Class IIID-0320-2024

Product

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11

Affected lot / code info

Lot #: 1012275, Exp 02/28/2025

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Recalling firm

Firm

Amerisource Health Services LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188

Distribution

Quantity

2,850 cartons

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-02-01

FDA classified

2024-02-08

Posted by FDA

2024-02-14

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0320-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.