FDA recall D-0628-2020

Product

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.

Reason for recall

Subpotent Drug: Supplier indicated assay results did not meet specifications.

Distribution

Nationwide in the USA and Canada

Key facts

Status

Terminated

Initiation date

2019-12-11

Report date

2020-01-01

Termination date

2023-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gardena, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2020