NALBUPHINE HCL 20 MG/ML INJECTABLE — Class II drug recall D-983-2013
Terminated recall by Beacon Hill Medical Pharmacy, P.C., reported 2013-09-18, distributed nationwide. Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control
| Recall number | D-983-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beacon Hill Medical Pharmacy, P.C., Southfield, MI, United States |
| Recall initiated | 2013-07-26 |
| Classified | 2013-09-10 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-07-18 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Reason for recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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-983-2013. 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.