Reported Apr 19, 2017 · Terminated
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC…
Medisca, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medisca, Inc. · 661 State Route 3 Unit C · Plattsburgh, NY · 12901-6531
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | 5 grams (NDC 38779-0732-03) |
| — | 25 grams (NDC 38779-0732-04) |
| — | 100 grams (NDC 38779-0732-05), and |
0732 | 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901 |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I 2 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H 3 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A 4 126317/A, 127296/A, 138646/F - Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
This product could cause temporary or reversible health problems — stop using it.
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