FDA recall D-0592-2018

American Pharmaceutical Ingredients LLC · Class II · drug

Product

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients

Reason for recall

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2018-03-07
Report date: 2018-03-21
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-0592-2018