Why it was recalled
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
Product description
Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S.A. Natonwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0353-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 11, 2018
- FDA report date
- Dec 26, 2018
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asclemed USA Inc. dba Enovachem
Original FDA data
Every field from FDA enforcement report D-0353-2019, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 81741
- Address
- 379 Van Ness Ave Ste 1403
- Code information
- 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
- Postal code
- 90501-7211
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0353-2019
- Classification
- Class I
- Recalling firm
- Asclemed USA Inc. dba Enovachem
- Termination date
- Feb 1, 2023
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
- Distribution pattern
- U.S.A. Natonwide
- Recall initiation date
- Dec 11, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jan 9, 2019