Dyural-40 Injection Kit Recalled for Incorrect Latex Labeling
Asclemed USA Inc. is recalling Dyural-40 Injection Kits because the product insert incorrectly states that the stoppers do not contain latex, when they actually do.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric, as it involves a labeling error regarding a common allergen (latex) that could cause serious adverse health consequences.
Plain-English summary
Asclemed USA Inc. dba Enovachem is recalling Dyural-40 Injection Kits, 1 Dose, Single Use Only, Rx only. The recall is due to a labeling error where the product insert incorrectly states 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 specific lots involved include 050518X5, 051618X1, 052318X4, 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, 082318X4, 083118X1, 090518X4, 091818X4, 091818X3, 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, and 102418X5, with expiration dates ranging from January 31, 2019, to September 30, 2019.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. Individuals with a known latex allergy should consult their healthcare provider regarding the use of these kits.
The recalled product
- Product
- Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
- 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 #: 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
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
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