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

Class I - Dangerous

💊 Drugs Recalled: December 11, 2018 Asclemed USA Inc. Prescription Drugs

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Asclemed USA Inc. dba Enovachem
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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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