FDA recall D-1074-2015

Fallon Wellness Pharmacy, L.L.C. · Class II · drug

Product

Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL 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-1074-2015