FDA recall D-0666-2017

Product

ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261

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-0666-2017