FDA Drug · D-0558-2020

fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50

Class II · Terminated

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

Affected lots / codes — check yours against thisLots: 10029773 Exp. 11/17/2019, 10029821 Exp. 11/18/2019, 10030351 Exp. 11/21/2019, 10031014 Exp. 12/2/2019, 10030351 Exp. 11/21/2019, 10030912 Exp. 12/2/2019, 10030569 Exp. 11/28/2019, 10030966 Exp. 12/3/2019, 10031796 Exp. 12/23/2019, 10031509 Exp. 12/17/2019, 10031067 Exp. 12/5/2019, 10031156 Exp. 12/16/2019

Recalling firm: QuVa Pharma, Inc., Sugar Land, TX
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: —
Distribution: Nationwide.
Recall initiated: November 12, 2019
Classified: December 3, 2019
Terminated: June 5, 2020
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0558-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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