Medisca, Inc. recalls 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)
Recalled April 19, 2017 · FDA recall D-0664-2017 · Medisca
Hazard
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection · FDA Class II
Units
N/A
Sold at
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Description
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Product
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
Manufacturer(s)
Medisca, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →