FDA recall D-1633-2015

Product

Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-02

Report date

2015-09-23

Termination date

2016-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Knoxville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1633-2015