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

Recall Number: D-0666-2017

Firm: Medisca, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170419

Initiation Date: 20170403

Termination Date: 20190618

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

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