PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 19, 2017 Initiated: April 3, 2017 #D-0664-2017

Product Description

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

Reason for Recall

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Details

Recalling Firm
Medisca, Inc.
Units Affected
N/A
Distribution
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Location
Plattsburgh, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Medisca, Inc.. Units affected: N/A.
Why was this product recalled?
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Which agency issued this recall?
This recall was issued by the FDA Drug on April 19, 2017. Severity: Moderate. Recall number: D-0664-2017.