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-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
Lot numbers, UPCs & expiration codes
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, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, Exp 6/30/2019; 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, Exp 7/31/19; 103118X3, 110618X1, 110818X1, 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-0354-2019
- 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-0354-2019, 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 # 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, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, Exp 6/30/2019; 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, Exp 7/31/19; 103118X3, 110618X1, 110818X1, Exp 9/30/19
- Postal code
- 90501-7211
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0354-2019
- 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-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
- Distribution pattern
- U.S.A. Natonwide
- Recall initiation date
- Dec 11, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jan 9, 2019