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Recall Observatory FDA recall evidence

Drug product

Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

D-0664-2018

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-0664-2018

Official wording

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

Code information: Lot#: 20180130@61, BUD 07/29/2018; 20180208@17, BUD 08/07/2018, 20170928@27, BUD 03/27/2018; 20171025@49, BUD 04/23/2018; 20171109@42, BUD 05/08/2018; 20171117@1, BUD 05/16/2018; 20180130@96, BUD 07/29/2018.

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.