Reported Apr 19, 2017 · Terminated
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (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?
8 of 8 products
| Model / number | Product as published |
|---|---|
| — | 100 mg (NDC 38779-0869-07) |
| — | 1 g (NDC 38779-0869-06) |
| — | 5 g (NDC 38779-0869-03) |
| — | 10 g (NDC 38779-0869-01) |
| — | 25 g (NDC 38779-0869-04) |
| — | 100 g (NDC 38779-0869-05) |
| — | 500 g (NDC 38779-0869-08) |
0869 | 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901 |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 137169/F 2 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E 3 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D 4 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C 5 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B 6 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F 7 129670/B, 130942/B, 131429/B, 131430/B 8 129670/A, 130942/A ,131429/A, 131430/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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