fentaNYL — Class II drug recall D-0872-2017
Terminated recall by SCA Pharmaceuticals, reported 2017-06-07, distributed nationwide. Lack of assurance of sterility: Product bags leaking at seam.
| Recall number | D-0872-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Little Rock, AR, United States |
| Recall initiated | 2017-05-18 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 118 bags |
| Reason classes | sterility, packaging |
| NDC | 70004-0229-32 |
| Expiration dates | 2017-08-03, 2017-08-08 |
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Reason for recall
Lack of assurance of sterility: Product bags leaking at seam.
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-0872-2017. 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.