CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

FDA Recall #D-0139-2021 — Class II — November 30, 2020

Recall #D-0139-2021 Date: November 30, 2020 Classification: Class II Status: Ongoing

Product Description

CEREBROLYSIN, 107.5 MG/ML, 10 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

1 vial

Distribution

CA, CO, FL, IN, KY, OH, TX

Code Information

Lot #1110202004 Exp 12/10/2020

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated