CLASS II Drug recall · Reported 15 Jan 2020 · FDA Enforcement Report
Estriol, USP, (Micronized) recalled by Asclemed USA
Asclemed USA is recalling Estriol, USP, (Micronized), distributed in California. The recall was initiated on 9 Dec 2019 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-0652-2020
- FDA event ID
- 84550
- Recalling firm
- Asclemed USA, Torrance, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2019
- FDA classified
- 8 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 9 Dec 2019 | Recall initiated by company | |
| 8 Jan 2020 | Classified by FDA | +30 days |
| 15 Jan 2020 | 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
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Where it was distributed
Product was distributed to 6 physician's offices within the state of California.
Questions about this recall
Is Estriol, USP, (Micronized) recalled?
Yes. Asclemed USA recalled Estriol, USP, (Micronized) on 9 Dec 2019. The recall is Class II and its status is Terminated. Recall number D-0652-2020.
Why was it recalled?
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Which lots are affected?
Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, EXP 8/31/2021
Where was it sold?
Product was distributed to 6 physician's offices within the state of California.
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.
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|---|---|---|---|---|---|
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