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Recall Observatory FDA recall evidence

Drug product

B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

D-0635-2018

March 22, 2018

Class II

Product summary

Firm
Partell Specialty Pharmacy
Event
Event 79619
Status
Terminated
Classification
Class II
Quantity
5 vials
Official record key
drug-enforcement:D-0635-2018

Official wording

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

Code information: Lot#: 20180205@18, BUD 04/06/2018; 20180126@28, BUD 03/27/2018; 20180126@22, BUD 03/27/2018; 20180205@9, BUD 04/06/2018; 20180214@17, BUD 04/14/2018.

Distribution pattern: NV only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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