CLASS II Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report
Estriol, USP (Micronized) Bulk, in a) recalled by Medisca
Medisca is recalling Estriol, USP (Micronized) Bulk, in a) (, 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
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-0663-2017
- 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
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
Where it was distributed
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Questions about this recall
Is Estriol, USP (Micronized) Bulk, in a) ( recalled?
Yes. Medisca recalled Estriol, USP (Micronized) Bulk, in a) ( on 3 Apr 2017. The recall is Class II and its status is Terminated. Recall number D-0663-2017.
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) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medisca
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|---|---|---|---|---|---|
| Drug | CLASS II | Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Budesonide, USP (Micronized), 500 mg recalled by Medisca | Medisca | Particulate Matter | Nationwide |
| Drug | CLASS II | Estriol, USP (Micronized), containers recalled by Medisca | Medisca | Potency & Assay | Nationwide |
| Drug | CLASS II | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estrone, USP Bulk, in a) 100 mgs recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |