FDA-Drug2017-04-19Class II
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
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
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0666-2017Don't want to check this manually?
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