FDAFDA · Food and drugs·Recall number D-0694-2016
papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Published February 24, 2016 · Recall initiated: January 15, 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: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Distributor
- CA
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States