Drug product
MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
D-0656-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0656-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: Lot #: 20180223@1, BUD 04/24/2018; 20180129@5, BUD 03/30/2018; 20180126@4, BUD 03/27/2018; 20180215@22, BUD 04/16/2018; 20180122@10, 20180126@4, BUD 03/23/2018; 20180202@27, BUD 04/03/2018; 20180208@5, 20180201@2, BUD 04/02/2018; # 20180207@2, BUD 04/08/2018, 20180214@11, BUD 04/15/2018; 20180215@22, BUD 04/16/2018.
Distribution pattern: NV only
Derived failure modes
-
Unknown
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.