fentaNYL 2 mcg/mL — Class II drug recall D-0946-2018
Terminated recall by Avella of Deer Valley, Inc. Store 38, reported 2018-07-25, distributed nationwide. Lack of Assurance of Sterility: Potential leakage of bags.
| Recall number | D-0946-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avella of Deer Valley, Inc. Store 38, Phoenix, AZ, United States |
| Recall initiated | 2018-06-12 |
| Classified | 2018-07-19 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2020-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 100 cassettes |
| Reason classes | sterility, packaging |
| NDC | 15082-0278-86 |
| Lot numbers | 1012, 172-27886Y |
| Expiration dates | 2018-06-28 |
Product
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
Reason for recall
Lack of Assurance of Sterility: Potential leakage of bags.
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-0946-2018. 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.