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Recall Observatory FDA recall evidence

Drug product

Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

D-0642-2018

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-0642-2018

Official wording

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

Code information: a) Lot #: 20180123@9, 20171222@11, BUD 4/14/2018, 20180214@7, BUD 08/14/2018. b) Lot #: 20180221@3,BUD 08/21/2018, 20180214@6; BUD 08/14/2018.

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.