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
Recall initiated: 20170403
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated