D-0320-2024 Class III Terminated
FDA drug recall D-0320-2024 was initiated by Amerisource Health Services LLC on Feb 1, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. The recall status is terminated (terminated Sep 1, 2026). Affected quantity: 2,850 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 14, 2024
- Initiation Date
- Feb 1, 2024
- Termination Date
- Sep 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,850 cartons
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1012275, Exp 02/28/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0320-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026