CLASS I Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report

Dyural-80 Injection Kit, 1 Dose, Single Use Only recalled

Asclemed USA is recalling Dyural-80 Injection Kit, 1 Dose, Single Use Only. The recall was initiated on 11 Dec 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot # 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

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0354-2019
FDA event ID: 81741
Recalling firm: Asclemed USA, Torrance, CA
Classification: Class I
Status: Terminated
Recall initiated: 11 Dec 2018
FDA classified: 9 Jan 2019
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Foreign Material
Drug class: Injectable & IV Drugs

Timeline

11 Dec 2018	Recall initiated by company
26 Dec 2018	Published in enforcement report	+15 days
9 Jan 2019	Classified by FDA	+14 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

U.S.A. Natonwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

U.S.A. Natonwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 81741

This product is part of a recall event; the main page for the event is Dyural-40 Injection Kit, 1 Dose, Single Use Only recalled.

Reported	Class	Recall	Company	Reason	Where
26 Dec 2018	CLASS I	Dyural-40 Injection Kit, 1 Dose, Single Use Only recalled	Asclemed USA	Foreign Material	CA

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