CLASS II Drug recall · Reported 15 Jan 2014 · FDA Enforcement Report
Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj units recalled
Compounding Centre At Blue Ridge is recalling Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj units, distributed in North Carolina. The recall was initiated on 18 Oct 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-405-2014
- FDA event ID
- 66568
- Recalling firm
- Compounding Centre At Blue Ridge, Raleigh, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2013
- FDA classified
- 9 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 18 Oct 2013 | Recall initiated by company | |
| 9 Jan 2014 | Classified by FDA | +83 days |
| 15 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
NC
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lots
Where was it sold?
NC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 66568This product is part of a recall event; the main page for the event is Quad Mix Injectable recalled by Compounding Centre At Blue.
More recalls from Compounding Centre At Blue Ridge
All 5Other Papaverine recalls
All 64| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled | Pharmacy Plus | Sterility | 4 states |