Letco Medical Recalls Subpotent Estriol USP Micronized Drug Products

Plain-English summary

Letco Medical LLC, based in Decatur, Alabama, is voluntarily recalling specific lots of Estriol USP Micronized drug products. The recall was initiated on January 10, 2020, and was classified as Class II by the FDA. The affected products are prescription-only (Rx Only) and were repackaged by Letco Medical LLC.

The reason for the recall is that the products were found to be subpotent, meaning they did not contain the full labeled amount of the active ingredient. The affected lots include various jar sizes (1 gm, 5 gm, 25 gm, 100 gm, 500 gm, and 1 kg) with specific NDC numbers and expiration dates ranging from June 2020 to September 2021. The total quantity involved is 3,685 jars across six product sizes.

The products were distributed in the United States, Australia, Canada, Israel, the Philippines, and Taiwan. The recall was initiated by the firm and was terminated on April 7, 2021. Consumers and healthcare providers should check their inventory against the specific lot numbers and expiration dates listed in the official recall notice to determine if they are affected.

The recalled product

Product

Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601

Manufacturer

Letco Medical LLC

Category

Drug — Prescription Drug

Hazard

• subpotent

Is your product affected?

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

Distribution

Distribution scope not specified by the agency.

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