Estriol recall: Impurity Out of Spec
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Why was Estriol recalled?
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
- Product
- Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Quantity
- 8.52 gm
- Distribution
- Product was distributed to 6 physician's offices within the state of California.
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)