Dyural-40 Injection Kit (Enovachem) – labeling issue (2018)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Brand
Asclemed USA Inc. dba Enovachem
Lot Codes / Batch Numbers
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
Products Sold
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
Asclemed USA Inc. dba Enovachem is recalling Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, due to Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert inco. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026