Home / Recalls / Qinhuangdao Zizhu Pharmaceutical, Co. / D-0657-2017

D-0657-2017 Class II Terminated

Recalled by Qinhuangdao Zizhu Pharmaceutical, Co. — Qinhuangdao, 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

Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)

Reason for Recall

cGMP Deviations; lack of quality assurance.

Distribution Pattern

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

Code Information

Batch 82801505001 to 82801606001, exp 5/4/2017 through 5/19/2018

Other recalls by Qinhuangdao Zizhu Pharmaceutical, Co.

  • D-0660-2017 Class II — Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, (March 24, 2017)
  • D-0654-2017 Class II — Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured b (March 24, 2017)
  • D-0656-2017 Class II — Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactur (March 24, 2017)
  • D-0655-2017 Class II — Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manu (March 24, 2017)
  • D-0659-2017 Class II — Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, (March 24, 2017)
  • D-0658-2017 Class II — Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactur (March 24, 2017)