PlainRecalls
FDA Drug Critical Class I Terminated

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01

Reported: December 26, 2018 Initiated: December 11, 2018 #D-0353-2019

Product Description

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01

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 stoppers contain natural rubber latex

Details

Distribution
U.S.A. Natonwide
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01. Recalled by Asclemed USA Inc. dba Enovachem.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on December 26, 2018. Severity: Critical. Recall number: D-0353-2019.