Agency classClass IIOur severity:Severe FDA (Drugs)·D-0658-2017·Announced 2017-04-19

FDA Recalls Testosterone Micronized Bulk Due to cGMP Deviations

Qinhuangdao Zizhu Pharmaceutical is recalling Testosterone Micronized Bulk due to cGMP deviations and lack of quality assurance. The product was distributed to six states.

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 FDA classifies this recall as Class II. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), particularly when structural or quality assurance failures like cGMP deviations are involved.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone Micronized, Bulk, manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd. The recall is due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The product is intended for prescription compounding and is available by prescription only.

The affected product is identified by NDC 44132-006-06. The recall covers batches 78801507001 through 78901612003, with expiration dates ranging from June 22, 2017, to November 21, 2018. The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. 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: Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
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 78801507001 to 78901612003
exp 6/22/2017 through 11/21/2018

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