The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0650-2020·Announced 2020-01-15

Enovachem Recalls Estriol USP 0.06 g Due to Impurity Failures

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.06 g, due to 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.06 g, distributed in Torrance, California. The recall is being conducted because additional testing revealed out-of-specification impurity test results, indicating the product failed to meet required quality standards.

The affected product is identified by NDC #76420-049-36. Specific lot codes and expiration dates associated with the recall include 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, and 09061903, all with an expiration date of 12/31/2020. The product was distributed to six physician's offices within the state of California.

Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
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 (8)

  • Lot Code/Exp. Date: 11061901
  • 04011903
  • 04221904
  • 04241904
  • 06031902
  • 07301905
  • 09061903
  • EXP 12/31/2020

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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