Skip to content
Recall Observatory FDA recall evidence

Drug product

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

D-0568-2020

November 12, 2019

Class II

Product summary

Firm
QuVa Pharma, Inc.
Event
Event 84263
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0568-2020

Official wording

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

Code information: Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020

Distribution pattern: Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter