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Home Public Health Agencies US Department of Agriculture Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits...

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

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Abstract

Firm Announcement Date:
December 17, 2018
FDA Publish Date:
June 06, 2019
Product Kind:
Medication

Motive for Announcement:
Firm Title:
Asclemed USA Inc dba Envoachem Pharmeceuticals
Model Title:

Model Title(s)

Envoachem Prescribed drugs

Product Description:


Firm Announcement

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 plenty of Dyural-40 and 61 plenty of Dyural-80, to the person stage. The merchandise embody recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled because of product labeling incorrectly stating stoppers don’t comprise latex.

For the inhabitants most in danger, these with a extreme allergic response to latex, there may be chance of an anaphylactic response, and this might lead to hospitalization or dying. So far, Asclemed USA Inc has not obtained any experiences of adversarial occasions associated to this recall.

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

The affected Dyural-40 heaps embody the next:

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 heaps embody the next:

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 merchandise will be recognized by lot and expiration stamped on the entrance of every comfort package. Product was distributed Nationwide to distributors and physicians.

Asclemed USA Inc is notifying its distributors and prospects by e-mail and is arranging for return of all recalled merchandise. Distributors and physicians which have Dyural-40 or Dyural-80 which is being recalled ought to cease utilizing them and return to position of buy.

Customers with questions relating to this recall can contact Asclemed USA Inc by calling (310) 320-0100 ext. 120 Monday via Friday from 7:30am to 4:00pm PST or emailing christinah@enovachem.us.com. Customers ought to contact their doctor or healthcare supplier if they’ve skilled any issues that could be associated to taking or utilizing this drug product.

Hostile reactions or high quality issues skilled with using this product could also be reported to the FDA’s MedWatch Hostile Occasion Reporting program both on-line, by common mail or by fax.

This recall is being carried out with the data of the U.S. Meals and Drug Administration.


Firm Contact Info

Media:
Christina Hopson


Product Photographs



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