FDA recall D-1508-2016

W & C dba The Apothecary · Class II · drug

Product

Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, 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-1508-2016