Medications & Supplements/Prescription Drugs

Asclemed USA Inc. dba Enovachem Pharmaceuticals: Estriol (USP Micronized) Recalled Due to Failed Impurity Specifications

Agency Publication Date: January 7, 2020

Summary

Asclemed USA Inc., doing business as Enovachem Pharmaceuticals, has recalled approximately 107 units of Estriol, USP (Micronized) in various strengths (0.06 g, 0.12 g, and 0.24 g). This recall was initiated because laboratory testing found out-of-specification levels of impurities and degradation products. These products were distributed to six physician's offices in California between 2018 and 2019 and carry expiration dates through August 2021. Consumers should check their medication packaging for specific lot numbers to determine if their product is affected.

Risk

The presence of impurities or degradation products that exceed safety specifications can mean the medication is less effective or could potentially cause unexpected side effects or adverse reactions due to the breakdown of the active ingredient.

What You Should Do

Check your Estriol USP (Micronized) packaging for the NDC numbers 76420-049-36 (0.06 g), 76420-049-37 (0.12 g), or 76420-049-38 (0.24 g).
For 0.06 g Estriol, verify if your lot number is 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, or 09061903 with expiration date 12/31/2020.
For 0.12 g Estriol, check for lot numbers 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902 (Exp 12/31/2020); 08161901, 10111903 (Exp 5/31/2021); or 11211904, 10161901 (Exp 8/31/2021).
For 0.24 g Estriol, check for lot numbers 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); or 11211902, 10311902 (Exp 8/31/2021).
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.
Return any unused product to the place of purchase or contact Enovachem Pharmaceuticals at 379 Van Ness Ave Ste 1403, Torrance, California for further instructions.
For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return product to pharmacy for refund and consult healthcare provider.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Estriol, USP, (Micronized), 0.06 g

Model:

NCD #76420-049-36

Lot Numbers:

11061901 (Exp 12/31/2020)

04011903 (Exp 12/31/2020)

04221904 (Exp 12/31/2020)

04241904 (Exp 12/31/2020)

06031902 (Exp 12/31/2020)

07301905 (Exp 12/31/2020)

09061903 (Exp 12/31/2020)

Date Ranges: EXP 12/31/2020

Product: Estriol, USP, (Micronized), 0.12 g

Model:

NCD #76420-049-37

Lot Numbers:

11061901 (Exp 12/31/2020)

11061803 (Exp 12/31/2020)

11281804 (Exp 12/31/2020)

11291804 (Exp 12/31/2020)

04171902 (Exp 12/31/2020)

05201901 (Exp 12/31/2020)

08121902 (Exp 12/31/2020)

08161901 (Exp 5/31/2021)

10111903 (Exp 5/31/2021)

11211904 (Exp 8/31/2021)

10161901 (Exp 8/31/2021)

Date Ranges: EXP 12/31/2020, EXP 5/31/2021, EXP 8/31/2021

Product: Estriol, USP, (Micronized), 0.24 g

Model:

NCD #76420-049-38

Lot Numbers:

11191804 (Exp 12/31/2020)

12281802 (Exp 12/31/2020)

01211902 (Exp 12/31/2020)

01281901 (Exp 12/31/2020)

02071903 (Exp 12/31/2020)

02221902 (Exp 12/31/2020)

03111903 (Exp 12/31/2020)

03251902 (Exp 12/31/2020)

04011905 (Exp 12/31/2020)

04091903 (Exp 12/31/2020)

04221907 (Exp 12/31/2020)

05211902 (Exp 12/31/2020)

06071902 (Exp 12/31/2020)

06241903 (Exp 12/31/2020)

07111903 (Exp 12/31/2020)

07301902 (Exp 12/31/2020)

08271902 (Exp 12/31/2020)

09061904 (Exp 12/31/2020)

09161902 (Exp 12/31/2020)

09161901 (Exp 5/31/2021)

10091905 (Exp 5/31/2021)

10221902 (Exp 5/31/2021)

10311901 (Exp 5/31/2021)

11211902 (Exp 8/31/2021)

10311902 (Exp 8/31/2021)

Date Ranges: EXP 12/31/2020, EXP 5/31/2021, EXP 8/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84550

Status: Resolved

Manufacturer: Asclemed USA Inc. dba Enovachem Pharmaceuticals

Sold By: physician's offices

Manufactured In: United States

Units Affected: 3 products (8.52 gm; 42.12 gm; 56.4 gm)

Distributed To: California

Agency Last Updated: January 8, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Estriol USP (Micronized) packaging for the NDC numbers 76420-049-36 (0.06 g), 76420-049-37 (0.12 g), or 76420-049-38 (0.24 g).

For 0.06 g Estriol, verify if your lot number is 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, or 09061903 with expiration date 12/31/2020.

For 0.12 g Estriol, check for lot numbers 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902 (Exp 12/31/2020); 08161901, 10111903 (Exp 5/31/2021); or 11211904, 10161901 (Exp 8/31/2021).

For 0.24 g Estriol, check for lot numbers 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); or 11211902, 10311902 (Exp 8/31/2021).

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.

Return any unused product to the place of purchase or contact Enovachem Pharmaceuticals at 379 Van Ness Ave Ste 1403, Torrance, California for further instructions.

For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Estriol, USP, (Micronized), 0.06 g

Model:

NCD #76420-049-36

Lot Numbers:

11061901 (Exp 12/31/2020)

04011903 (Exp 12/31/2020)

04221904 (Exp 12/31/2020)

04241904 (Exp 12/31/2020)

06031902 (Exp 12/31/2020)

07301905 (Exp 12/31/2020)

09061903 (Exp 12/31/2020)

Date Ranges: EXP 12/31/2020

Product: Estriol, USP, (Micronized), 0.12 g

Model:

NCD #76420-049-37

Lot Numbers:

11061901 (Exp 12/31/2020)

11061803 (Exp 12/31/2020)

11281804 (Exp 12/31/2020)

11291804 (Exp 12/31/2020)

04171902 (Exp 12/31/2020)

05201901 (Exp 12/31/2020)

08121902 (Exp 12/31/2020)

08161901 (Exp 5/31/2021)

10111903 (Exp 5/31/2021)

11211904 (Exp 8/31/2021)

10161901 (Exp 8/31/2021)

Date Ranges: EXP 12/31/2020, EXP 5/31/2021, EXP 8/31/2021

Product: Estriol, USP, (Micronized), 0.24 g

Model:

NCD #76420-049-38

Lot Numbers:

11191804 (Exp 12/31/2020)

12281802 (Exp 12/31/2020)

01211902 (Exp 12/31/2020)

01281901 (Exp 12/31/2020)

02071903 (Exp 12/31/2020)

02221902 (Exp 12/31/2020)

03111903 (Exp 12/31/2020)

03251902 (Exp 12/31/2020)

04011905 (Exp 12/31/2020)

04091903 (Exp 12/31/2020)

04221907 (Exp 12/31/2020)

05211902 (Exp 12/31/2020)

06071902 (Exp 12/31/2020)

06241903 (Exp 12/31/2020)

07111903 (Exp 12/31/2020)

07301902 (Exp 12/31/2020)

08271902 (Exp 12/31/2020)

09061904 (Exp 12/31/2020)

09161902 (Exp 12/31/2020)

09161901 (Exp 5/31/2021)

10091905 (Exp 5/31/2021)

10221902 (Exp 5/31/2021)

10311901 (Exp 5/31/2021)

11211902 (Exp 8/31/2021)

10311902 (Exp 8/31/2021)

Date Ranges: EXP 12/31/2020, EXP 5/31/2021, EXP 8/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84550

Status: Resolved

Manufacturer: Asclemed USA Inc. dba Enovachem Pharmaceuticals

Sold By: physician's offices

Manufactured In: United States

Units Affected: 3 products (8.52 gm; 42.12 gm; 56.4 gm)

Distributed To: California

Agency Last Updated: January 8, 2020