FDA recall D-0665-2017

Medisca, Inc. · Class II · drug

Product

ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869

Reason for recall

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Distribution

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

Key facts

Status: Terminated
Initiation date: 2017-04-03
Report date: 2017-04-19
Termination date: 2019-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2017