FDAFDA · Food and drugs·Recall number D-0039-2024
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
Published October 11, 2023 · Recall initiated: September 1, 2023
Status when published: Terminated — 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 results in the repackaged product for impurities at the 12-month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot#: 1007002, Exp 12/31/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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