PlainRecalls
FDA Drug Moderate Class II Terminated

Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),

Reported: April 19, 2017 Initiated: March 24, 2017 #D-0660-2017

Product Description

Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),

Reason for Recall

cGMP Deviations; lack of quality assurance.

Details

Units Affected
N/A
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ
Location
Qinhuangdao, N/A

Frequently Asked Questions

What product was recalled?
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),. Recalled by Qinhuangdao Zizhu Pharmaceutical, Co.. Units affected: N/A.
Why was this product recalled?
cGMP Deviations; lack of quality assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 19, 2017. Severity: Moderate. Recall number: D-0660-2017.