The Recall Desk
ModerateFDA (Drugs)·D-0654-2017·Announced 2017-04-19

FDA Recalls Estradiol Micronized Bulk Due to cGMP Deviations

Qinhuangdao Zizhu Pharmaceutical is recalling Estradiol Micronized Bulk for prescription compounding 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 FDA classifies this as a Class II recall, and the source text cites cGMP deviations and lack of quality assurance without reporting specific illnesses or injuries, aligning with the rubric for moderate severity involving voluntary precautionary or quality-based recalls.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Micronized Bulk, a prescription-only product intended for prescription compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, located in Qinhuangdao, China. The recall covers NDC 44132-001-01 and 44132-001-06.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The affected batches range from Batch 80001512002 to Batch 80801604003, with expiration dates ranging from 10/22/2017 through 3/30/3018. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
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 80001512002 to Batch 80801604003
  • exp 10/22/2017 through 3/30/3018

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 deviation

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