FDA recall D-0490-2018

Product

Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.

Reason for recall

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Distribution

Nationwide within USA.

Key facts

Status

Terminated

Initiation date

2018-02-09

Report date

2018-02-28

Termination date

2019-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waterford, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2018