FDA-Drug2017-04-19Class II
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
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
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2017Don't want to check this manually?
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