Estradiol Micronized Bulk recall: CGMP Deviations
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China…
Why was Estradiol Micronized Bulk 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 80001512002 to Batch 80801604003, exp 10/22/2017 through 3/30/3018
- Product
- Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China…
- 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)