The Recall Desk
ModerateFDA (Drugs)·D-0656-2017·Announced 2017-04-19

FDA Recalls Estriol Micronized Bulk Drug Due to Quality Assurance Failures

Qinhuangdao Zizhu Pharmaceutical is recalling bulk Estriol Micronized, USP, due to cGMP deviations and lack of quality assurance. The product is distributed to pharmacies in six states for prescription compounding.

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, but the source text cites cGMP deviations and lack of quality assurance without reporting specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving voluntary precautionary recalls or low-risk contamination where harm is not yet reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, located in Qinhuangdao, China. The recall is being conducted due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance.

The affected product includes batches 81801504002 through 81801701003, with expiration dates ranging from April 12, 2017, to January 19, 2019. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey. Because this is a bulk ingredient intended for prescription compounding, it is not sold directly to consumers but is used by pharmacies to prepare specific medications.

Pharmacies and compounding facilities should stop using the affected batches and return them to the manufacturer or follow the instructions provided by the recalling firm. Patients who have already received compounded medications made with this specific ingredient should consult their healthcare provider or pharmacist for guidance on whether they need to take any action.

The recalled product

Product
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
Manufacturer
Qinhuangdao Zizhu Pharmaceutical, Co.
Category
Drug — Bulk Pharmaceutical Ingredient
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 81801504002 to 81801701003
  • exp 4/12/2017 through 1/19/2019

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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