CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Prostaglandin Rx, dispensed in vials: 10 mcg/mL Injection recalled
Fallon Wellness Pharmacy is recalling Prostaglandin Rx, dispensed in vials: 10 mcg/mL Injection, 22.5 mcg/mL Injection, 45, 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-1068-2015
- 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
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/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#: a) 10272014@1, Exp 4/27/15; b) 11042014@60, Exp 4/12/15; c) 11192014@43, Exp 4/12/15; d) 12042014@32, Exp 4/12/15; e) 12182014@46; Exp 4/12/15; f) 12232014@8, 12242014@16, Exp 4/12/15; g) 12312014@40, 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 Prostaglandin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prostaglandin 20 mcg/mL/Procaine 0.1% Injection recalled | First Pharma Associates | Sterility | ID, WA |
| Drug | CLASS II | Prostaglandin 20 mcg/mL Vial recalled by Anderson Compounding Pharmacy | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Prostaglandin 60 mcg/mL, Vial recalled by Anderson Compounding Pharmacy | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Prostaglandin 40 mcg/mL, Vial recalled by Anderson Compounding Pharmacy | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Prostaglandin 200 mcg/ -- Glass Vial recalled by W & C | W & C | Sterility | MN |