Reported Dec 26, 2018 · Terminated
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA…
Asclemed USA Inc. dba Enovachem
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Asclemed USA Inc. dba Enovachem · 379 Van Ness Ave Ste 1403 · Torrance, CA · 90501-7211
Is this the product you have?
- Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
- Lot codes and dates
Lot #: 050518X5051618X1Exp 1/31/19052318X4Exp 5/1/19052318X5062818X1072518X3072718X1080318X2091818X2Exp 5/31/19082318X4083118X1090518X4091818X4Exp 6/30/19091818X3Exp 7/31/19091818X5092418X1092818X4101018X3101018X5Exp 8/31/19102418X5Exp 9/30/19
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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