FDAFDA · Food and drugs·Recall number D-0353-2019
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Published December 26, 2018 · Recall initiated: December 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Asclemed USA Inc. dba Enovachem
- Distributor
- U.S.A. Natonwide
- Lot
- Lot #: 050518X5, 051618X1, Exp 1/31/19; 052318X4, Exp 5/1/19; 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, Exp 5/31/19; 082318X4, 083118X1, 090518X4, 091818X4, Exp 6/30/19; 091818X3, Exp 7/31/19; 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, Exp 8/31/19; 102418X5, Exp 9/30/19
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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