FDA recall D-0663-2017

Product

ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732

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-0663-2017