BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson...
FDA Recall #D-0776-2022 — Class II — April 5, 2022
Product Description
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Reason for Recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recalling Firm
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — Richardson, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
778 vials
Distribution
Nationwide within United States
Code Information
Lot #: 32242 BUD: 4/19/2022; 33911 BUD: 6/8/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated