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CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

FDA Recall #D-0128-2021 — Class II — November 30, 2020

Recall #D-0128-2021 Date: November 30, 2020 Classification: Class II Status: Ongoing

Product Description

CJC-1295, 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

6 vials

Distribution

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

Code Information

Lot #1029202004, Exp 11/29/2020; Lot #1102202001, 102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202003, Exp 12/10/2020; Lot #1112202004, Exp 12/12/2020

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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