fentaNYL 200 mcg/100 mL — Class II drug recall D-0550-2020
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 number | D-0550-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QuVa Pharma, Inc., Sugar Land, TX, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 70092-1104-36 |
| Lot numbers | 1002929, 10029806, 10029839, 10029840, 10029860, 10030001, 10030002, 10030003, 10030013, 10030014, 10030370, 10030429, 10030538, 10030905, 10030906, 10031039, 10031040, 10031151, 10031200, 10031282, 10031412, 10031432, 10031460, 10031461, 10031462, 10031475, 10031476, 10031566, 10031567, 10031613, 10031614, 10031641, 10031667, 10031668, 10031695, 10031788, 10031789, 10031790, 10031811, 10031812 and 32 more |
| Expiration dates | 2019-11-14, 2019-11-18, 2019-11-19, 2019-11-24, 2019-11-25, 2019-11-26, 2019-11-28, 2019-12-05, 2019-12-08, 2019-12-10, 2019-12-11, 2019-12-15, 2019-12-16, 2019-12-18, 2019-12-19, 2019-12-20, 2019-12-22, 2019-12-23, 2019-12-24, 2019-12-25, 2019-12-27, 2019-12-29, 2019-12-30, 2019-12-31, 2020-01-01 and 6 more |
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
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-0550-2020. 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.