Medications & Supplements/Prescription Drugs

Asclemed USA Inc. dba Enovachem: Dyural Injection Kits Recalled for Incorrect Latex Labeling

Agency Publication Date: December 20, 2018

Summary

Asclemed USA Inc. (dba Enovachem) is recalling several lots of Dyural-40 and Dyural-80 Injection Kits. These medical kits include a Sodium Chloride 0.9% solution where the product insert incorrectly states that the vial stoppers do not contain latex. In reality, the stoppers are made with natural rubber latex, which can cause severe reactions in people with latex sensitivities. These prescription kits were distributed nationwide across the United States.

Risk

The vial stoppers contain natural rubber latex despite labeling to the contrary, posing a risk of serious allergic reactions or anaphylaxis to patients or healthcare providers with a latex allergy.

What You Should Do

Check your medical supplies for Dyural-40 Injection Kits (NDC 76420-0750-01) with lot numbers 050518X5, 051618X1, 052318X4, 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, 082318X4, 083118X1, 090518X4, 091818X4, 091818X3, 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, or 102418X5.
Check for Dyural-80 Injection Kits (NDC 76420-0755-01) with any of the affected lot numbers, including 050918X1, 051618X10, 051818X4, 071718X2, 061118X8, 051518X4, 051818X5, 052118X4, 052118X5, 052918X7, 061118X9, 061118X10, 061418X2, 061518X1, 061518X2, 061918X2, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, 103118X3, 110618X1, or 110818X1.
Immediately stop using any kits from the affected lots if you or the patient have a known latex allergy.
Contact your healthcare provider or pharmacist for guidance regarding the use of these kits and to discuss alternative treatments.
Return any unused product to the pharmacy or place of purchase for a refund and contact Asclemed USA Inc. (dba Enovachem) at their Torrance, CA location for further return instructions.
If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dyural-40 Injection Kit, 1 Dose, Single Use Only

Model:

NDC 76420-0750-01

Lot Numbers:

050518X5 (Exp 1/31/19)

051618X1 (Exp 1/31/19)

052318X4 (Exp 5/1/19)

052318X5 (Exp 5/31/19)

062818X1 (Exp 5/31/19)

072518X3 (Exp 5/31/19)

072718X1 (Exp 5/31/19)

080318X2 (Exp 5/31/19)

091818X2 (Exp 5/31/19)

082318X4 (Exp 6/30/19)

083118X1 (Exp 6/30/19)

090518X4 (Exp 6/30/19)

091818X4 (Exp 6/30/19)

091818X3 (Exp 7/31/19)

091818X5 (Exp 8/31/19)

092418X1 (Exp 8/31/19)

092818X4 (Exp 8/31/19)

101018X3 (Exp 8/31/19)

101018X5 (Exp 8/31/19)

102418X5 (Exp 9/30/19)

Date Ranges: Exp 1/31/19, Exp 5/1/19, Exp 5/31/19, Exp 6/30/19, Exp 7/31/19, Exp 8/31/19, Exp 9/30/19

Product: Dyural-80 Injection Kit, 1 Dose, Single Use Only

Model:

NDC 76420-0755-01

Lot Numbers (61):

050918X1 (Exp 12/31/18)

051618X10 (Exp 12/31/18)

051818X4 (Exp 12/31/18)

071718X2 (Exp 2/28/19)

061118X8 (Exp 5/1/19)

051518X4 (Exp 5/31/19)

051818X5 (Exp 5/31/19)

052118X4 (Exp 5/31/19)

052118X5 (Exp 5/31/19)

052918X7 (Exp 5/31/19)

061118X9 (Exp 5/31/19)

061118X10 (Exp 5/31/19)

061418X2 (Exp 5/31/19)

061518X1 (Exp 5/31/19)

061518X2 (Exp 6/30/2019)

061918X2 (Exp 6/30/2019)

062518X2 (Exp 6/30/2019)

062718X1 (Exp 6/30/2019)

062718X2 (Exp 6/30/2019)

062818X3 (Exp 6/30/2019)

062818X4 (Exp 6/30/2019)

070918X1 (Exp 6/30/2019)

071018X5 (Exp 6/30/2019)

071118X4 (Exp 6/30/2019)

071118X5 (Exp 6/30/2019)

072018X6 (Exp 6/30/2019)

072418X3 (Exp 6/30/2019)

072418X4 (Exp 6/30/2019)

072518X2 (Exp 6/30/2019)

073018X4 (Exp 6/30/2019)

073018X8 (Exp 6/30/2019)

080218X3 (Exp 6/30/2019)

080718X7 (Exp 6/30/2019)

080918X3 (Exp 6/30/2019)

083018X2 (Exp 6/30/2019)

083118X2 (Exp 6/30/2019)

083118X5 (Exp 6/30/2019)

090518X5 (Exp 6/30/2019)

090518X6 (Exp 7/31/19)

090718X2 (Exp 7/31/19)

090718X3 (Exp 7/31/19)

090718X5 (Exp 7/31/19)

091118X7 (Exp 7/31/19)

091318X5 (Exp 7/31/19)

091918X1 (Exp 7/31/19)

092718X1 (Exp 7/31/19)

092718X2 (Exp 7/31/19)

092818X3 (Exp 7/31/19)

100518X6 (Exp 7/31/19)

101118X3 (Exp 7/31/19)

Date Ranges: Exp 12/31/18, Exp 2/28/19, Exp 5/1/19, Exp 5/31/19, Exp 6/30/2019, Exp 7/31/19, Exp 9/30/19

Product Images

Image 1 - Product labeling Enovachem Pharmaceuticals Dyural-40

Image 1 - Product labeling Enovachem Pharmaceuticals Dyural-80

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81741

Status: Resolved

Manufacturer: Asclemed USA Inc. dba Enovachem

Sold By: Healthcare providers; Pharmacies

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: January 9, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Dyural-40 Injection Kits (NDC 76420-0750-01) with lot numbers 050518X5, 051618X1, 052318X4, 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, 082318X4, 083118X1, 090518X4, 091818X4, 091818X3, 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, or 102418X5.

Check for Dyural-80 Injection Kits (NDC 76420-0755-01) with any of the affected lot numbers, including 050918X1, 051618X10, 051818X4, 071718X2, 061118X8, 051518X4, 051818X5, 052118X4, 052118X5, 052918X7, 061118X9, 061118X10, 061418X2, 061518X1, 061518X2, 061918X2, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, 103118X3, 110618X1, or 110818X1.

Immediately stop using any kits from the affected lots if you or the patient have a known latex allergy.

Contact your healthcare provider or pharmacist for guidance regarding the use of these kits and to discuss alternative treatments.

Return any unused product to the pharmacy or place of purchase for a refund and contact Asclemed USA Inc. (dba Enovachem) at their Torrance, CA location for further return instructions.

If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Dyural-40 Injection Kit, 1 Dose, Single Use Only

Model:

NDC 76420-0750-01

Lot Numbers:

050518X5 (Exp 1/31/19)

051618X1 (Exp 1/31/19)

052318X4 (Exp 5/1/19)

052318X5 (Exp 5/31/19)

062818X1 (Exp 5/31/19)

072518X3 (Exp 5/31/19)

072718X1 (Exp 5/31/19)

080318X2 (Exp 5/31/19)

091818X2 (Exp 5/31/19)

082318X4 (Exp 6/30/19)

083118X1 (Exp 6/30/19)

090518X4 (Exp 6/30/19)

091818X4 (Exp 6/30/19)

091818X3 (Exp 7/31/19)

091818X5 (Exp 8/31/19)

092418X1 (Exp 8/31/19)

092818X4 (Exp 8/31/19)

101018X3 (Exp 8/31/19)

101018X5 (Exp 8/31/19)

102418X5 (Exp 9/30/19)

Date Ranges: Exp 1/31/19, Exp 5/1/19, Exp 5/31/19, Exp 6/30/19, Exp 7/31/19, Exp 8/31/19, Exp 9/30/19

Product: Dyural-80 Injection Kit, 1 Dose, Single Use Only

Model:

NDC 76420-0755-01

Lot Numbers (61):

050918X1 (Exp 12/31/18)

051618X10 (Exp 12/31/18)

051818X4 (Exp 12/31/18)

071718X2 (Exp 2/28/19)

061118X8 (Exp 5/1/19)

051518X4 (Exp 5/31/19)

051818X5 (Exp 5/31/19)

052118X4 (Exp 5/31/19)

052118X5 (Exp 5/31/19)

052918X7 (Exp 5/31/19)

061118X9 (Exp 5/31/19)

061118X10 (Exp 5/31/19)

061418X2 (Exp 5/31/19)

061518X1 (Exp 5/31/19)

061518X2 (Exp 6/30/2019)

061918X2 (Exp 6/30/2019)

062518X2 (Exp 6/30/2019)

062718X1 (Exp 6/30/2019)

062718X2 (Exp 6/30/2019)

062818X3 (Exp 6/30/2019)

062818X4 (Exp 6/30/2019)

070918X1 (Exp 6/30/2019)

071018X5 (Exp 6/30/2019)

071118X4 (Exp 6/30/2019)

071118X5 (Exp 6/30/2019)

072018X6 (Exp 6/30/2019)

072418X3 (Exp 6/30/2019)

072418X4 (Exp 6/30/2019)

072518X2 (Exp 6/30/2019)

073018X4 (Exp 6/30/2019)

073018X8 (Exp 6/30/2019)

080218X3 (Exp 6/30/2019)

080718X7 (Exp 6/30/2019)

080918X3 (Exp 6/30/2019)

083018X2 (Exp 6/30/2019)

083118X2 (Exp 6/30/2019)

083118X5 (Exp 6/30/2019)

090518X5 (Exp 6/30/2019)

090518X6 (Exp 7/31/19)

090718X2 (Exp 7/31/19)

090718X3 (Exp 7/31/19)

090718X5 (Exp 7/31/19)

091118X7 (Exp 7/31/19)

091318X5 (Exp 7/31/19)

091918X1 (Exp 7/31/19)

092718X1 (Exp 7/31/19)

092718X2 (Exp 7/31/19)

092818X3 (Exp 7/31/19)

100518X6 (Exp 7/31/19)

101118X3 (Exp 7/31/19)

Date Ranges: Exp 12/31/18, Exp 2/28/19, Exp 5/1/19, Exp 5/31/19, Exp 6/30/2019, Exp 7/31/19, Exp 9/30/19