Dyural-40 Injection Kit — Class I drug recall D-0353-2019
Terminated recall by Asclemed USA Inc. dba Enovachem, reported 2018-12-26. Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the man
| Recall number | D-0353-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asclemed USA Inc. dba Enovachem, Torrance, CA, United States |
| Recall initiated | 2018-12-11 |
| Classified | 2019-01-09 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2023-02-01 |
| Reason classes | labeling |
| NDC | 76420-0750-01 |
| Lot numbers | 050518X5, 051618X1, 052318X4, 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 082318X4, 083118X1, 090518X4, 091818X2, 091818X3, 091818X4, 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, 102418X5 |
| Expiration dates | 2019-01-31, 2019-05-01, 2019-05-31, 2019-06-30, 2019-07-31, 2019-08-31, 2019-09-30 |
Product
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0353-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.