Recalls / Class II

Class IID-0662-2018

Product

Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3

Affected lot / code info

Lot#: 20171128@9, BUD 05/27/2018; 20171201@74, BUD 05/30/2018; 20171211@68, BUD 06/09/2018; 20171218@51, BUD 06/16/2018; 20171222@6, BUD 06/20/2018; 20180209@62, BUD 08/08/2018; 20180223@46, BUD 08/22/2018; 20180223@33, BUD 08/22/2018; 20180219@5, BUD 08/18/2018; 20171010@11, BUD 04/08/2018; 20171019@19, BUD 04/17/2018; 20171031@69, BUD 04/29/2018; 20171102@27, BUD 05/01/2018; 20171110@87, BUD 05/09/2018; 20171114@12, BUD 05/13/2018; 20171122@57, BUD 05/21/2018; 20180112@56, BUD 07/11/2018; 20180116@77, BUD 07/15/2018; 20180122@92, BUD 07/21/2018; 20180202@69, BUD 08/01/2018; 20180205@111, BUD 08/04/2018; 20180212@102, BUD 08/11/2018.

Why it was recalled

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

Recalling firm

Firm

Partell Specialty Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5835 S Eastern Ave Ste 101, Las Vegas, Nevada 89119-3031

Distribution

Distribution pattern

NV only

Timeline

Recall initiated

2018-03-22

FDA classified

2018-04-17

Posted by FDA

2018-04-25

Terminated

2019-01-15

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0662-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.