FDA Recall D-0353-2019

Asclemed USA Inc. dba Enovachem · Torrance, CA

Class I — life-threatening Terminated 1513 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: Lot #: 050518X5, 051618X1, Exp 1/31/19; 052318X4, Exp 5/1/19; 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, Exp 5/31/19; 082318X4, 083118X1, 090518X4, 091818X4, Exp 6/30/19; 091818X3, Exp 7/31/19; 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, Exp 8/31/19; 102418X5, Exp 9/30/19

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

Recall record

Recall number: D-0353-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: U.S.A. Natonwide
Recall initiated: 2018-12-11
Classified by FDA Center: 2019-01-09
FDA published: 2018-12-26
Terminated: 2023-02-01
Recalling firm: Asclemed USA Inc. dba Enovachem
Firm location: Torrance, CA

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