FDAFDA · Food and drugs·Recall number D-0320-2024
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
Published February 14, 2024 · Recall initiated: February 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 1012275, Exp 02/28/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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