FDA Drug · D-0563-2020

fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36

Class II · Terminated

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

Affected lots / codes — check yours against thisLots: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020

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-0563-2020%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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