D-0131-2021 Class II Ongoing
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
AOD-9604, 1200 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 #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020