Asclemed USA Inc. dba Enovachem recalls Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501…

Recall date

December 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0354-2019

FDA classification

Class I

Brand / firm

Asclemed USA Inc. dba Enovachem

Sold / distributed

U.S.A. Natonwide

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

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