CLASS II Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Prostaglandin 200 mcg/ -- Glass Vial recalled by W & C
W & C is recalling Prostaglandin 200 mcg/ -- Glass Vial, distributed in Minnesota. The recall was initiated on 20 Jun 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-1512-2016
- FDA event ID
- 74606
- Recalling firm
- W & C, Sartell, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jun 2016
- FDA classified
- 16 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Jun 2016 | Recall initiated by company | |
| 16 Sep 2016 | Classified by FDA | +88 days |
| 28 Sep 2016 | Published in enforcement report | +12 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: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
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 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Where it was distributed
MN
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Which lots are affected?
LOT #: 06201604@15, 19201602@3, 06201604@8
Where was it sold?
MN
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 74606This product is part of a recall event; the main page for the event is Calcium Gluconate 1% -- Viaflex IV recalled by W & C.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Calcium Gluconate 1% -- Viaflex IV recalled by W & C | W & C | Sterility | MN | |
| CLASS II | Calcium Gluconate 2.5% -- Plastic Syringe recalled by W & C | W & C | Sterility | MN | |
| CLASS II | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin recalled by W & C | W & C | Sterility | MN | |
| CLASS II | Papaverine 30 mg / Phentolamine 1 mg / mL -- Glass Vial recalled | W & C | Sterility | MN |
More recalls from W & C
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papaverine 30 mg / Phentolamine 1 mg / mL -- Glass Vial recalled | W & C | Sterility | MN |
| Drug | CLASS II | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin recalled by W & C | W & C | Sterility | MN |
| Drug | CLASS II | Calcium Gluconate 2.5% -- Plastic Syringe recalled by W & C | W & C | Sterility | MN |
| Drug | CLASS II | Calcium Gluconate 1% -- Viaflex IV recalled by W & C | W & C | Sterility | MN |
Other 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 Rx, dispensed in vials: 10 mcg/mL Injection recalled | Fallon Wellness Pharmacy | Sterility | NY |