RecallRadar

FDA Drug recall D-0566-2020

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Lan…

On 2019-12-11 the FDA classified a Class II recall of fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Lan… by Quva Pharma, citing presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0566-2020
ClassificationClass II
Statusterminated
Initiated2019-11-12
Published2019-12-11
Last updated2026-09-13 11:52 UTC
CompanyQuva Pharma
DistributionUS

Product

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47

Reason

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

Identifiers

code_info
Lots: 10030359 Exp. 11/21/2019, 10030549 Exp. 11/28/2019, 10031169 Exp. 12/8/2019, 10031491 Exp. 12/16/2019, 100318…Lots: 10030359 Exp. 11/21/2019, 10030549 Exp. 11/28/2019, 10031169 Exp. 12/8/2019, 10031491 Exp. 12/16/2019, 10031879 Exp. 12/24/2019, 10032317 Exp. 12/31/2019, 10032265 Exp. 12/30/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0566-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.