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Recall Observatory FDA recall evidence

Drug product

Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

D-0673-2018

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-0673-2018

Official wording

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

Code information: Lot#: 20171201@84, BUD: 05/30/2018; 20180125@31, BUD 07/24/2018; 20180209@106, BUD 08/08/2018; 20171011@69, BUD 04/09/2018; 20171019@10, BUD 04/17/2018; 20171106@103, BUD 05/05/2018.

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.