FDA Drug recall D-0354-2019

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01

FDA Drug
Class I
terminated
Published 2018-12-26

On 2018-12-26 the FDA classified a Class I recall of Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01 by Asclemed Usa, citing 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 n….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0354-2019
Classification	Class I
Status	terminated
Initiated	2018-12-11
Published	2018-12-26
Last updated	2026-09-13 11:52 UTC
Company	Asclemed Usa
Distribution	n/a

Product

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01

Reason

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

Identifiers

code_info	Lot # 050918X1, 051618X10, 051818X4, Exp 12/31/18; 071718X2, Exp 2/28/19; 061118X8, Exp 5/1/19; 051518X4, 051818X5, 052… Lot # 050918X1, 051618X10, 051818X4, Exp 12/31/18; 071718X2, Exp 2/28/19; 061118X8, Exp 5/1/19; 051518X4, 051818X5, 052118X4, 052118X5, 052918X7, 061118X9, 061118X10, 061418X2, 061518X1, Exp 5/31/19; 061518X2, 061918X2, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, Exp 6/30/2019; 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, Exp 7/31/19; 103118X3, 110618X1, 110818X1, Exp 9/30/19

code_info

Lot # 050918X1, 051618X10, 051818X4, Exp 12/31/18; 071718X2, Exp 2/28/19; 061118X8, Exp 5/1/19; 051518X4, 051818X5, 052…

Lot # 050918X1, 051618X10, 051818X4, Exp 12/31/18; 071718X2, Exp 2/28/19; 061118X8, Exp 5/1/19; 051518X4, 051818X5, 052118X4, 052118X5, 052918X7, 061118X9, 061118X10, 061418X2, 061518X1, Exp 5/31/19; 061518X2, 061918X2, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, Exp 6/30/2019; 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, Exp 7/31/19; 103118X3, 110618X1, 110818X1, Exp 9/30/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0354-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.