FDA recall D-0718-2022

Product

Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00

Reason for recall

Sub Potent

Distribution

Nationwide in the USA including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2022-03-08

Report date

2022-03-30

Termination date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0718-2022