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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

D-0644-2018

March 22, 2018

Class II

Product summary

Firm
Partell Specialty Pharmacy
Event
Event 79619
Status
Terminated
Classification
Class II
Quantity
7 vials
Official record key
drug-enforcement:D-0644-2018

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@2, BUD 7/29/2018; 20180109@1, BUD 07/08/2018; 20180212@51, BUD 08/11/2018;, 20171212@4, BUD 06/10/2018; 20180123@6, BUD 07/22/2018; 20171204@4, BUD 06/02/2018; 20171228@15, BUD 03/28/2018.

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.