FDAClass IIApril 19, 2017

Estradiol Non-Micronized recall: CGMP Deviations

Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao…

Why was Estradiol Non-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 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018

Product
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao…
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