Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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 stoppers contain natural rubber latex
What was recalled
Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
- Recalling firm
- Asclemed USA Inc. dba Enovachem
- NDC code
- 76420-0755-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0354-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.