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
Reported: April 19, 2017 Initiated: April 3, 2017 #D-0663-2017
Product Description
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
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? ▼
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. 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-0663-2017.
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