CLASS II Drug recall · Reported 14 Dec 2016 · FDA Enforcement Report
Papa/Phen/Prost (papverine/phentolamine/prostaglandin) recalled
Fallon Wellness Pharmacy is recalling Papa/Phen/Prost (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, distributed in New York. The recall was initiated on 2 Nov 2016 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-0173-2017
- FDA event ID
- 75695
- Recalling firm
- Fallon Wellness Pharmacy, Latham, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- 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
| 2 Nov 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +36 days |
| 14 Dec 2016 | 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: product produced on a day there was an excursion in environmental monitoring data.
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
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Where it was distributed
NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Which lots are affected?
Lot #: 09192016@41,09192016@69, Exp 11/04/2016
Where was it sold?
NY
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
1 other product · FDA event 75695This product is part of a recall event; the main page for the event is Papa/Phen/Prost (papverine/phentolamine/prostaglandin) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Papa/Phen/Prost (papverine/phentolamine/prostaglandin) recalled | Fallon Wellness Pharmacy | Sterility | NY |
More recalls from Fallon Wellness Pharmacy
All 13Other Papa recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papa/Phen/Prost (papverine/phentolamine/prostaglandin) recalled | Fallon Wellness Pharmacy | Sterility | NY |
| Drug | CLASS II | Papa/PGE1/Phento (30mg/50mcg/0.5mg/ml), Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (35mg/12mcg/1.5mg/ml), Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (30mg/40mcg/1mg/ml) Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (15mg/5mcg/0.5mg/ml) Injection and vials recalled | Pacific Healthcare | Sterility | CA, NJ |