PlainRecalls
FDA Drug Moderate Class II Terminated

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50

Reported: December 11, 2019 Initiated: November 12, 2019 #D-0572-2020

Product Description

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50

Reason for Recall

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Details

Recalling Firm
QuVa Pharma, Inc.
Distribution
Nationwide.
Location
Sugar Land, TX

Frequently Asked Questions

What product was recalled?
fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50. Recalled by QuVa Pharma, Inc..
Why was this product recalled?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which agency issued this recall?
This recall was issued by the FDA Drug on December 11, 2019. Severity: Moderate. Recall number: D-0572-2020.