FDAClass IIApril 19, 2017

Testosterone Micronized recall: CGMP Deviations

Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004…

Why was Testosterone Micronized recalled?

cGMP Deviations; lack of quality assurance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch 78801507001 to 78901612003, exp 6/22/2017 through 11/21/2018

Product
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004…
Recalling firm
Qinhuangdao Zizhu Pharmaceutical, Co.
Quantity
N/A
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls