FDA recall D-325-2016

Product

Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Reason for recall

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-03

Report date

2015-11-25

Termination date

2017-12-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peoria, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-325-2016