D-0660-2017 Class II Terminated

Recalled by Qinhuangdao Zizhu Pharmaceutical, Co. — Qinhuangdao, N/A

FDA drug recall D-0660-2017 was initiated by Qinhuangdao Zizhu Pharmaceutical, Co. on March 24, 2017 and is designated Class II. Reason for recall: cGMP Deviations; lack of quality assurance. The recall status is terminated (terminated July 3, 2018). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
April 19, 2017
Initiation Date
March 24, 2017
Termination Date
July 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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.

Distribution Pattern

Product distributed to NY, TX, SC, CO, MN and NJ

Code Information

Batch 70001602009, 2/21/2021