Recalls / Class II

Class IID-0656-2018

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

Affected lot / code info

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.

Why it was recalled

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Recalling firm

Firm

Partell Specialty Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5835 S Eastern Ave Ste 101, Las Vegas, Nevada 89119-3031

Distribution

Distribution pattern

NV only

Timeline

Recall initiated

2018-03-22

FDA classified

2018-04-17

Posted by FDA

2018-04-25

Terminated

2019-01-15

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0656-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.