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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

D-0655-2018

March 22, 2018

Class II

Product summary

Firm
Partell Specialty Pharmacy
Event
Event 79619
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0655-2018

Official wording

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

Code information: Lot#: a) 20180119@4, 20171016@10, 20171106@5, 20171214@55, 20180207@5 BUD 04/14/2018; 20180212@15, BUD 03/29/2018; 20180117@26, BUD 07/16/2018. b) 20180219@17, BUD 08/18/2018; 20180205@1, 20180102@39, 20180124@3, BUD 04/14/2018; 20180221@23, BUD 08/20/2018.

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.