Drug recall
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by…
FDA recall event 89663 · Class II · The Harvard Drug Group
Key facts
| Event ID | 89663 |
|---|---|
| Recall numbers | D-0653-2022 |
| Recalling firm | The Harvard Drug Group |
| Product type | Drugs |
| Products | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. |
| Initiation date | Feb 24, 2022 |
| Report date | Mar 23, 2022 |
| Termination date | Jul 16, 2023 |
| City | Livonia |
| State | MI |
| Country | United States |
| FEI number | 1818658 |
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: