Drug & medication recalls Moderate risk

Letco Medical LLC recalls 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…

Recall date
January 10, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0780-2020
FDA classification
Class II
Brand / firm
Letco Medical LLC
Sold / distributed
United States, Australia, Canada, Israel, Philippines, Taiwan.

Why it was recalled

Subpotent

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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