The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0651-2020·Announced 2020-01-15

Enovachem Recalls Estriol USP Micronized Due to Impurity Test Failures

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling specific lots of Estriol, USP, (Micronized), 0.12 g, because additional testing found Out of Specification impurity test results.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any specific illnesses, injuries, or hospitalizations, aligning with the rubric for moderate severity involving low-risk contamination or precautionary measures.

Plain-English summary

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling specific lots of Estriol, USP, (Micronized), 0.12 g. The recall was initiated because additional testing revealed Out of Specification impurity test results for the product.

The affected product was distributed to six physician's offices within the state of California. The recall covers specific lot codes and expiration dates, including lots with expiration dates of 12/31/2020, 5/31/2021, and 8/31/2021.

Patients who have received this medication should contact their healthcare provider for guidance on next steps. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Manufacturer
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Category
Drug — Pharmaceutical
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Lot Code/Exp. Date: 11061901
  • 11061803
  • 11281804
  • 11291804
  • 04171902
  • 05201901
  • 08121902
  • EXP 12/31/2020
  • 08161901
  • 10111903
  • EXP 5/31/2021
  • 11211904
  • 10161901
  • EXP 8/31/2021

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Asclemed USA Inc. dba Enovachem Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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