FDA Drug recall 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
- FDA Drug
- Class I
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class I recall of Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01 by Asclemed Usa, citing 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 n….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0353-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-12-11 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Asclemed Usa |
| Distribution | n/a |
Product
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Reason
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
Identifiers
| code_info | Lot #: 050518X5, 051618X1, Exp 1/31/19; 052318X4, Exp 5/1/19; 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2019%22
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