Papaverine/Phentolamine 30 mg/mL/2 — Class II drug recall D-405-2014
Terminated recall by Compounding Centre At Blue Ridge, reported 2014-01-15, distributed in NC. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subj
| Recall number | D-405-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Compounding Centre At Blue Ridge, Raleigh, NC, United States |
| Recall initiated | 2013-10-18 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2017-04-19 |
| Distributed | NC |
| Reason classes | sterility |
| Lot numbers | MG/ML/2.0 |
Product
Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Reason for recall
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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-405-2014. 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.