FDA recall D-0780-2020

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

Reason for recall

Subpotent

Distribution

United States, Australia, Canada, Israel, Philippines, Taiwan.

Key facts

Status

Terminated

Initiation date

2020-01-10

Report date

2020-01-22

Termination date

2021-04-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Decatur, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0780-2020