D-0731-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- January 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 vials
Product Description
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Reason for Recall
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Distribution Pattern
The recalled product was distributed to patients throughout the United States.
Code Information
Lot #: 03052018@54, Exp 06/03/2018