FDA-Drug2017-04-19Class II
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
Medisca, Inc.
Hazard
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Sold states
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Affected count
N/A
Manufactured in
661 State Route 3 Unit C, N/A, Plattsburgh, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0663-2017Don't want to check this manually?
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