FDA recall D-1511-2016

Product

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

MN

Key facts

Status

Terminated

Initiation date

2016-06-20

Report date

2016-09-28

Termination date

2017-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sartell, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1511-2016