CLASS II Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report

Estrone, USP Bulk, in a) 100 mgs recalled by Medisca

Medisca is recalling Estrone, USP Bulk, in a) 100 mgs (, distributed nationwide in the US. The recall was initiated on 3 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A

Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0664-2017
FDA event ID: 76873
Recalling firm: Medisca, Plattsburgh, NY
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2017
FDA classified: 12 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

3 Apr 2017	Recall initiated by company
12 Apr 2017	Classified by FDA	+9 days
19 Apr 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

a) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A

Where was it sold?

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 76873

This product is part of a recall event; the main page for the event is Estradiol, USP (Hemihydrate)(Micronized), in a) 100 mg recalled.

Reported	Class	Recall	Company	Reason	Where
19 Apr 2017	CLASS II	Estradiol, USP (Hemihydrate)(Micronized), in a) 100 mg recalled	Medisca	Manufacturing (CGMP) Deviations	Nationwide
19 Apr 2017	CLASS II	Estriol, USP (Micronized) Bulk, in a) recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide
19 Apr 2017	CLASS II	Estradiol, USP Bulk (Hemihydrate), in a) recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Medisca

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Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide
10 Jul 2024Drug	CLASS II	Budesonide, USP (Micronized), 500 mg recalled by Medisca	Medisca	Particulate Matter	Nationwide
25 Dec 2019Drug	CLASS II	Estriol, USP (Micronized), containers recalled by Medisca	Medisca	Potency & Assay	Nationwide
27 Sep 2017Drug	CLASS II	Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide
19 Apr 2017Drug	CLASS II	Estradiol, USP Bulk (Hemihydrate), in a) recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide

Other Estrone recalls

All 3

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019Drug	CLASS II	Estrone 5mg/mL Oil Injection Vial recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
21 Jun 2017Drug	CLASS II	Estrone recalled by American Pharmaceutical	American Pharmaceutical Ingredients	Manufacturing (CGMP) Deviations	6 states