Testosterone Micronized recalled over manufacturing violations
- Recall date
- March 24, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Qinhuangdao Zizhu Pharmaceutical, Co. recalls Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical…
- Recall number
- D-0658-2017
- FDA classification
- Class II
- Brand / firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Sold / distributed
- Product distributed to NY, TX, SC, CO, MN and NJ
Why it was recalled
cGMP Deviations; lack of quality assurance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
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