D-0134-2021 Class II Ongoing

Recalled by Advanced Nutriceuticals, LLC — Indianapolis, IN

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
November 30, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 vials

Product Description

IPAMORELIN, 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.

Distribution Pattern

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

Code Information

Lot # 1029202005,Exp 11/29/2020; Lot #1102202014, Exp 12/08/2020; Lot #1112202002, Exp 12/12/2020