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COMPANY ANNOUNCEMENT

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Summary

Company Announcement Date:
December 17, 2018
FDA Publish Date:
December 17, 2018
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to Latex Hazard
Company Name:
Asclemed USA Inc dba Envoachem Pharmeceuticals
Brand Name:
Brand Name(s)
Envoachem Pharmaceuticals
Product Description:
Product Description
Dyural-40 and Dyural-80

Company Announcement

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Asclemed USA Inc has not received any reports of adverse events related to this recall.

The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi.

The affected Dyural-40 lots include the following:

LOT EXP LOT EXP LOT EXP LOT EXP
051518X5 1/31/2019 072518X3 5/31/2019 090518X4 6/30/2019 092418X1 8/31/2019
051618X1 1/31/2019 072718X1 5/31/2019 091818X2 1/31/2019 092818X4 8/31/2019
052318X4 5/1/2019 080318X2 5/31/2019 091818X3 7/31/2019 101018X3 8/31/2019
052318X5 5/31/2019 082318X4 6/30/2019 091818X4 6/30/2019 101018X5 8/31/2019
062818X1 5/31/2019 083118X1 6/30/2019 091818X5 8/31/2019 102418X5 9/30/2019

The affected Dyural-80 lots include the following:

LOT EXP LOT EXP LOT EXP LOT EXP
050918X1 12/31/2018 062718X1 6/30/2019 080718X7 6/30/2019 100518X6 7/31/2019
051518X4 5/31/2019 062718X2 6/30/2019 080918X3 6/30/2019 101118X3 7/31/2019
051618X10 12/31/2018 062818X3 6/30/2019 083018X2 6/30/2019 101518X2 7/31/2019
051818X4 12/31/2018 062818X4 6/30/2019 083118X2 6/30/2019 101618X7 7/31/2019
051818X5 5/31/2019 070918X1 6/30/2019 083118X5 6/30/2019 101618X8 7/31/2019
052118X4 5/31/2019 071018X5 6/30/2019 090518X5 6/30/2019 101818X3 7/31/2019
052118X5 5/31/2019 071118X4 6/30/2019 090518X6 7/31/2019 101918X1 7/31/2019
052918X7 5/31/2019 071118X5 6/30/2019 090718X2 7/31/2019 102318X1 7/31/2019
061118X8 5/1/2019 071718X2 2/28/2019 090718X3 7/31/2019 103118X1 7/31/2019
061118X9 5/31/2019 072018X6 6/30/2019 090718X5 7/31/2019 103118X2 7/31/2019
061118X10 5/31/2019 072418X3 6/30/2019 091118X7 7/31/2019 103118X3 9/30/2019
061418X2 5/31/2019 072418X4 6/30/2019 091318X5 7/31/2019 110618X1 9/30/2019
061518X1 5/31/2019 072518X2 6/30/2019 091918X1 7/31/2019 110818X1 9/30/2019
061518X2 6/30/2019 073018X4 6/30/2019 092718X1 7/31/2019
061918X2 6/30/2019 073018X8 6/30/2019 092718X2 7/31/2019
062518X2 6/30/2019 080218X3 6/30/2019 092818X3 7/31/2019

The products can be identified by lot and expiration stamped on the front of each convenience kit. Product was distributed Nationwide to distributors and physicians.

Asclemed USA Inc is notifying its distributors and customers by email and is arranging for return of all recalled products. Distributors and physicians that have Dyural-40 or Dyural-80 which is being recalled should stop using them and return to place of purchase.

Consumers with questions regarding this recall can contact Asclemed USA Inc by calling (310) 320-0100 ext. 120 Monday through Friday from 7:30am to 4:00pm PST or emailing christinah@enovachem.us.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Asclemed USA Inc
(310) 320-0100 ext. 120
christinah@enovachem.us.com
Media:
Christina Hopson
(310) 320-0100 ext. 120

Product Photos