Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Estriol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Affected NDC
76420-0049-37
Compare with the code on your package — it is the most precise check available.
Drug: Estriol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Estriol NDC 76420-0049 |
1 g/g | Powder | Asclemed USA, Inc. | BULK INGREDIENT |
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0651-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estriol recalls
See all
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by Asclemed USA Inc. dba Enovachem Pharmaceuticals
All 2019 recalls
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Accucaine
Lack of Assurance of Sterility
Class II · Moderate risk
Duloxetine DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
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