Drug recall
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by…
FDA recall event 93089 · Class III · Amerisource Health Services LLC
Key facts
| Event ID | 93089 |
|---|---|
| Recall numbers | D-0039-2024 |
| Recalling firm | Amerisource Health Services LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. |
| Initiation date | Sep 1, 2023 |
| Report date | Oct 11, 2023 |
| Termination date | Jul 16, 2024 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: