Data Foundry

Drug recalls 2019

fentaNYL 1500 mcg/30 mL — Class II drug recall D-0551-2020

Terminated recall by QuVa Pharma, Inc., reported 2019-12-11, distributed nationwide. Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Recall numberD-0551-2020
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmQuVa Pharma, Inc., Sugar Land, TX, United States
Recall initiated2019-11-12
Classified2019-12-03
Reported by FDA2019-12-11
Terminated2020-06-05
DistributedNationwide (US)
Reason classesforeign material, specification failure
NDC70092-1099-49
Lot numbers10029820, 10029872, 10029873, 10029934, 10030567, 10030568, 10030868, 10030892, 10031209, 10031210, 10031211, 10031438, 10031439, 10031700, 10031766, 10032225, 10032260, 10032343
Expiration dates2019-11-18, 2019-11-19, 2019-11-28, 2019-12-02, 2019-12-09, 2019-12-12, 2019-12-15, 2019-12-22, 2019-12-26, 2019-12-29, 2019-12-30, 2019-12-31

Product

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0551-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.