Multi-event March 2017 FDA Recall Drug by Qinhuangdao Zizhu Pharmaceutical, Co.
This Multi-event Class II drug recall was voluntarily initiated by Qinhuangdao Zizhu Pharmaceutical, Co. on March 24, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations; lack of quality assurance.. The product was distributed in Product distributed to NY, TX, SC, CO, MN and NJ and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0660-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
Batch or Lot Expiration Information
Batch# Batch 70001602009, 2/21/2021
Recall Number: D-0654-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
Batch or Lot Expiration Information
Batch# Batch 80001512002 to Batch 80801604003, exp 10/22/2017 through 3/30/3018
Recall Number: D-0656-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
Batch or Lot Expiration Information
Batch# Batch 81801504002 to 81801701003, exp 4/12/2017 through 1/19/2019
Recall Number: D-0655-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
Batch or Lot Expiration Information
Batch# Batch 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018
Recall Number: D-0657-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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)
Batch or Lot Expiration Information
Batch# Batch 82801505001 to 82801606001, exp 5/4/2017 through 5/19/2018
Recall Number: D-0659-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
Batch or Lot Expiration Information
Batch# Batch 73801506007 to 73801603001, exp 5/31/2017 through 1/15/2018
Recall Number: D-0658-2017
cGMP Deviations; lack of quality assurance.
03-24-2017
04-19-2017
N/A
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Qinhuangdao Zizhu Pharmaceutical, Co.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product distributed to NY, TX, SC, CO, MN and NJ
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
Batch or Lot Expiration Information
Batch# Batch 78801507001 to 78901612003, exp 6/22/2017 through 11/21/2018
