FDA Drug recall D-405-2014
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 2…
- FDA Drug
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of 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 2… by Compounding Centre At Blue Ridge, citing 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 associat….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-405-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-18 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Compounding Centre At Blue Ridge |
| Distribution | NC |
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
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-405-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.