FDA-Drug2022-04-27Class II

BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Hazard

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Sold states
Nationwide within United States
Affected count
778 vials
Manufactured in
1736 N Greenville Ave, Richardson, TX, United States
Products
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2022

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief