FDAFDA · Food and drugs·Recall number D-1511-2016
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Published September 28, 2016 · Recall initiated: June 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- W & C dba The Apothecary
- Distributor
- MN
- Lot
- LOT #: 06201604@15, 19201602@3, 06201604@8
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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