FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures
The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score (4) according to the rubric, as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., located in Qinhuangdao, China. The recall covers specific NDCs: 44132-003-04, 44132-003-02, and 44132-003-06.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The affected batches range from 82801505001 to 82801606001, with expiration dates from May 4, 2017, through May 19, 2018. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
- Manufacturer
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Category
- Drug — Bulk Pharmaceutical
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch 82801505001 to 82801606001
- exp 5/4/2017 through 5/19/2018
Distribution
Part of a larger recall action
This product is one of 7 recalled by Qinhuangdao Zizhu Pharmaceutical, Co. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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