Enovachem Recalls Dyural-80 Injection Kits Due to Incorrect Latex Labeling
Enovachem is recalling Dyural-80 Injection Kits because the product insert incorrectly stated that the stoppers do not contain latex, when they actually contain natural rubber latex.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from latex exposure.
Plain-English summary
Asclemed USA Inc. dba Enovachem is recalling Dyural-80 Injection Kits, 1 Dose, Single Use Only, Rx only. The recall is due to a labeling error where the product insert incorrectly stated that the stoppers do not contain latex. In reality, the stoppers contain natural rubber latex.
The affected product is distributed nationwide in the U.S.A. The recall covers multiple lots with expiration dates ranging from December 31, 2018, to September 30, 2019. The specific lot numbers are listed in the structured product information provided by the FDA.
Individuals with a latex allergy should not use these kits. Healthcare providers and patients should check their inventory for the affected lot numbers and stop using the product if it matches the recall criteria. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
- Manufacturer
- Asclemed USA Inc. dba Enovachem
- Category
- Drug — Injection Kit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # 050918X1
- 051618X10
- 051818X4
- Exp 12/31/18
- 071718X2
- Exp 2/28/19
- 061118X8
- Exp 5/1/19
- 051518X4
- 051818X5
- 052118X4
- 052118X5
- 052918X7
- 061118X9
- 061118X10
- 061418X2
- 061518X1
- Exp 5/31/19
- 061518X2
- 061918X2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Asclemed USA Inc. dba Enovachem under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Asclemed USA Inc. dba Enovachem
See all →- SevereDyural-40 Injection Kit Recalled for Incorrect Latex Labeling
FDA (Drugs) · 2018-12-26
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
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