Dyural-40 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-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
- Recalling firm
- Asclemed USA Inc. dba Enovachem
- NDC code
- 76420-0750-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0353-2019
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.
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