D-0965-2020 Class II Terminated
FDA drug recall D-0965-2020 was initiated by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical on January 15, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated December 7, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2020
- Initiation Date
- January 15, 2020
- Termination Date
- December 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Code Information
Lot #: 09052019+52881, Exp 4/7/2020; 09302019+52977, Exp 5/2/2020; 10072019+53049, Exp 5/9/2020