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Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (ND...

FDA Recall #D-0235-2019 — Class II — October 17, 2018

Recall #D-0235-2019 Date: October 17, 2018 Classification: Class II Status: Terminated

Product Description

Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) 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: C245 BUD: 11/28/2018; D005 BUD: 1/5/2019; D027 BUD: 1/31/2019; D035 BUD: 2/9/2019; D058 BUD: 3/9/2019

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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