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Recall Observatory FDA recall evidence

Drug product

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76

D-0564-2020

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-0564-2020

Official wording

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

Code information: Lots: 10029361 Exp. 11/15/2019, 10029362 Exp. 11/15/2019, 10029334 Exp. 11/14/2019, 10029855 Exp. 11/19/2019, 10029856 Exp. 11/19/2019, 10030387 Exp. 11/25/2019, 10030388 Exp. 11/25/2019, 10031026 Exp. 12/12/2019, 10031078 Exp. 12/12/2019, 10031469 Exp. 12/16/2019, 10031493 Exp. 12/16/2019, 10031519 Exp. 12/17/2019, 10031804 Exp. 12/23/2019, 10031105 Exp. 12/12/2019, 10031830 Exp. 12/23/2019, 10031884 Exp. 12/24/2019, 10032704 Exp. 1/8/2020, 10032888 Exp. 1/12/2020, 10032889 Exp. 1/12/2020, 10032913 Exp. 1/13/2020, 10032939 Exp. 1/13/2020, 10032940 Exp. 1/13/2020

Distribution pattern: Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter