Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC ...

FDA Recall #D-0233-2019 — Class II — October 17, 2018

Recall #D-0233-2019 Date: October 17, 2018 Classification: Class II Status: Terminated

Product Description

Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Qualgen, LLC — Edmond, OK

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

Nationwide.

Code Information

Lots: C230 BUD: 11/1/2018; C233 BUD: 11/3/2018; C234 BUD: 11/9/2018; C237 BUD: 11/13/2018; C240 BUD: 11/15/2018; C242 BUD: 11/20/2018; C244 BUD: 11/27/2018; C248 BUD: 12/4/2018; C250 BUD: 12/6/2018; C252 BUD: 12/12/2018; C256 BUD: 12/14/2018; C258 BUD: 12/18/2018; C264 BUD: 12/27/2018; D006 BUD: 1/8/2019; D009 BUD: 1/10/2019; D013 BUD: 1/15/2019; D015 BUD: 1/17/2019; D019 BUD: 1/22/2019; D024 BUD: 1/29/2019; D028 BUD: 2/1/2019; D034 BUD: 2/8/2019; D041 BUD: 2/20/2019; D059 BUD: 3/13/2019; D063 BUD: 3/15/2019; D070 BUD: 3/26/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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