Drug recall
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance…
FDA recall event 81741 · Class I · Asclemed USA Inc. dba Enovachem
Key facts
| Event ID | 81741 |
|---|---|
| Recall numbers | D-0353-2019, D-0354-2019 |
| Recalling firm | Asclemed USA Inc. dba Enovachem |
| Product type | Drugs |
| Products | Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01, Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The… |
| Initiation date | Dec 11, 2018 |
| Report date | Dec 26, 2018 |
| Termination date | Feb 1, 2023 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 3001452204 |
At a glance
- 1–9 Products in this recall
- 1–9 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: