BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
FDA Recall #D-0132-2021 — Class II — November 30, 2020
Product Description
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling Firm
Advanced Nutriceuticals, LLC — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4 vials
Distribution
CA, CO, FL, IN, KY, OH, TX
Code Information
Lot #1102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202001, Exp 12/15/2020; Lot #1112202004, Exp 12/12/2020
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated