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Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx...

FDA Recall #D-0234-2019 — Class II — October 17, 2018

Recall #D-0234-2019 Date: October 17, 2018 Classification: Class II Status: Terminated

Product Description

Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), 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: C235 BUD: 11/10/2018; C241 BUD: 11/17/2018; C251 BUD: 12/8/2018; C265 BUD: 12/28/2018; D008 BUD: 1/9/2019; D018 BUD: 1/19/2019; D022 BUD: 1/25/2019; D032 BUD: 2/7/2019; D037 BUD: 2/13/2019; D057 BUD: 3/8/2019; D061 BUD: 3/14/2019; D069 BUD: 3/23/2019

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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