The Recall Desk
ModerateFDA (Drugs)·D-0655-2017·Announced 2017-04-19

FDA Recalls Estradiol Non-Micronized Bulk Due to cGMP Deviations

The FDA is recalling bulk Estradiol Non-Micronized, USP, manufactured by Qinhuangdao Zizhu Pharmaceutical, Co. due to cGMP deviations and lack of quality assurance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves cGMP deviations and lack of quality assurance, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/quality issues without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical, Co., located in Qinhuangdao, China. The recall is classified as Class II.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The affected product includes batches ranging from 80701510001 to 80001607002, with expiration dates from 10/22/2017 through 7/5/2018. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey.

Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternatives. The FDA advises that this recall is a precautionary measure to ensure product quality and safety.

The recalled product

Product
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
Manufacturer
Qinhuangdao Zizhu Pharmaceutical, Co.
Category
Drug — Bulk Pharmaceutical
Hazard

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 80701510001 to Batch 80001607002
  • exp 10/22/2017 through 7/5/2018

Distribution

Distributed in 6 states:

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.

See all 7 products in this recall →

Related recalls

Same manufacturer · Qinhuangdao Zizhu Pharmaceutical, Co.

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Same hazard · cGMP deviations

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