Reported Apr 19, 2017 · 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)…
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?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | 100 mgs (NDC 38779-0891-05) |
| — | 1 gram (NDC 38779-0891-06) |
| — | 5 grams (NDC 38779-0891-03) |
| — | 25 grams (NDC 38779-0891-04), and |
0891 | 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 124880/D,124880/O, 130940/J, 135312/E 2 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B 3 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C 4 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A 5 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A - 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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