fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

Class I - Dangerous

💊 Drugs Recalled: November 12, 2019 QuVa Pharma Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029977 Exp. 11/20/2019 10029978 Exp. 11/21/2019 10029979 Exp. 11/21/2019 10030041 Exp. 11/21/2019 10030043 Exp. 11/21/2019 10030396 Exp. 11/25/2019 10030960 Exp. 12/2/2019 10030961 Exp. 12/4/2019 10030962 Exp. 12/4/2019 10031010 Exp. 12/4/2019 10031011 Exp. 12/4/2019 10031012 Exp. 12/4/2019 10030960 Exp. 12/2/2019 10031086 Exp. 12/6/2019 10030960 Exp. 12/2/2019 10031263 Exp. 12/10/2019 10031262 Exp. 12/10/2019 10031413 Exp. 12/15/2019 10031463 Exp. 12/16/2019 10031696 Exp. 12/22/2019 10031947 Exp. 12/26/2019 10031948 Exp. 12/31/2019 10032414 Exp. 1/2/2020 10031978 Exp. 1/1/2020 10031948 Exp. 12/31/2019 10032412 Exp. 1/2/2020 10032413 Exp. 1/2/2020 10032687 Exp. 1/8/2020 10032723 Exp. 1/9/2020 10033037 Exp. 1/23/2020 10032929 Exp. 1/26/2020
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: QuVa Pharma, Inc.
Reason for Recall:: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

Product Codes/Lot Numbers:

Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029977 Exp. 11/20/2019 10029978 Exp. 11/21/2019 10029979 Exp. 11/21/2019 10030041 Exp. 11/21/2019 10030043 Exp. 11/21/2019 10030396 Exp. 11/25/2019 10030960 Exp. 12/2/2019 10030961 Exp. 12/4/2019 10030962 Exp. 12/4/2019 10031010 Exp. 12/4/2019 10031011 Exp. 12/4/2019 10031012 Exp. 12/4/2019 10030960 Exp. 12/2/2019 10031086 Exp. 12/6/2019 10030960 Exp. 12/2/2019 10031263 Exp. 12/10/2019 10031262 Exp. 12/10/2019 10031413 Exp. 12/15/2019 10031463 Exp. 12/16/2019 10031696 Exp. 12/22/2019 10031947 Exp. 12/26/2019 10031948 Exp. 12/31/2019 10032414 Exp. 1/2/2020 10031978 Exp. 1/1/2020 10031948 Exp. 12/31/2019 10032412 Exp. 1/2/2020 10032413 Exp. 1/2/2020 10032687 Exp. 1/8/2020 10032723 Exp. 1/9/2020 10033037 Exp. 1/23/2020 10032929 Exp. 1/26/2020