D-1511-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 28, 2016
- Initiation Date
- June 20, 2016
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 mL
Product Description
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
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.
Distribution Pattern
MN
Code Information
LOT #: 06201604@15, 19201602@3, 06201604@8