CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL recalled
Fallon Wellness Pharmacy is recalling Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness, distributed in New York. The recall was initiated on 17 Mar 2015 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-1071-2015
- FDA event ID
- 70807
- Recalling firm
- Fallon Wellness Pharmacy, Latham, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2015
- FDA classified
- 12 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Mar 2015 | Recall initiated by company | |
| 12 May 2015 | Classified by FDA | +56 days |
| 20 May 2015 | Published in enforcement report | +8 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
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/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Where it was distributed
New York
Questions about this recall
Why was it recalled?
Lack of assurance of sterility
Which lots are affected?
Lot#: 12012014@65; Exp 4/12/15
Where was it sold?
New York
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
9 other products · FDA event 70807This product is part of a recall event; the main page for the event is Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL recalled.
More recalls from Fallon Wellness Pharmacy
All 13Other 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 |