Agency classClass IIOur severity:Severe FDA (Drugs)·D-0659-2017·Announced 2017-04-19

FDA Recalls Ethinyl Estradiol Bulk Drug Due to Quality Assurance Failures

The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (Score 4) under the provided rubric, as it involves a product that may cause temporary or medically reversible health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Ethinyl Estradiol Micronized, USP, Bulk, which is intended for prescription compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, located in Qinhuangdao, China, and carries the NDC 44132-002-05.

The recall was initiated because the product was found to have Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The affected batches range from 73801506007 to 73801603001, with expiration dates between May 31, 2017, and January 15, 2018. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey.

Healthcare professionals and compounding pharmacies should stop using the affected product and contact the recalling firm for instructions on return or disposal. Consumers should not use this bulk ingredient for self-medication and should consult their healthcare provider if they have questions regarding prescriptions filled with this specific ingredient.

The recalled product

Product: Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
Manufacturer: Qinhuangdao Zizhu Pharmaceutical, Co.
Category: Drug — Bulk Pharmaceutical Ingredient
Hazard: cGMP-deviation
quality-assurance-failure

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 73801506007 to 73801603001
exp 5/31/2017 through 1/15/2018

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 →

Same manufacturer · Qinhuangdao Zizhu Pharmaceutical, Co.

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Same hazard · cGMP deviation