FDAClass IIApril 19, 2017

Ethinyl Estradiol Micronized recall: CGMP Deviations

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

Why was Ethinyl Estradiol 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 73801506007 to 73801603001, exp 5/31/2017 through 1/15/2018

Product
Ethinyl Estradiol 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