fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: 10029200 Exp. 11/18/2019, 10030347 Exp. 11/24/2019, 10031325 Exp. 12/16/2019, 10030939 Exp. 12/3/2019, 10031865 Exp. 12/24/2019, 10031758 Exp. 12/26/2019, 10031757 Exp. 12/26/2019, 10032275 Exp. 12/30/2019
- 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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Product Codes/Lot Numbers:
Lots: 10029200 Exp. 11/18/2019, 10030347 Exp. 11/24/2019, 10031325 Exp. 12/16/2019, 10030939 Exp. 12/3/2019, 10031865 Exp. 12/24/2019, 10031758 Exp. 12/26/2019, 10031757 Exp. 12/26/2019, 10032275 Exp. 12/30/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0565-2020
Related Recalls
Presence of Particulate Matter
Lack of Assurance of Sterility
Lack of Assurance of Sterility