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

FDA recall notice · announced October 11, 2023 · Amerisource Health Services

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot#: 1007002, Exp 12/31/2023
Quantity: 3,344 cartons
Status: Terminated
Products in this recall event:
- 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 ND (D-0039-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.