FDA recall D-1068-2015

Product

Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Reason for recall

Lack of assurance of sterility

Distribution

New York

Key facts

Status

Terminated

Initiation date

2015-03-17

Report date

2015-05-20

Termination date

2018-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Latham, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1068-2015