CLASS II Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report
Levonorgestrel Non-Micronized, USP, Bulk recalled by Qinhuangdao Zizhu
Qinhuangdao Zizhu Pharmaceutical is recalling Levonorgestrel Non-Micronized, USP, Bulk, distributed in Colorado, Minnesota, New Jersey, New York, South Carolina, Texas. The recall was initiated on 24 Mar 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0660-2017
- FDA event ID
- 76890
- Recalling firm
- Qinhuangdao Zizhu Pharmaceutical, Qinhuangdao, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Mar 2017
- FDA classified
- 11 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hormones & Birth Control
Timeline
| 24 Mar 2017 | Recall initiated by company | |
| 11 Apr 2017 | Classified by FDA | +18 days |
| 19 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations; lack of quality assurance.
Product as listed by the FDA
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
Where it was distributed
Product distributed to NY, TX, SC, CO, MN and NJ
Questions about this recall
Why was it recalled?
cGMP Deviations; lack of quality assurance.
Which lots are affected?
Batch 70001602009, 2/21/2021
Where was it sold?
Product distributed to NY, TX, SC, CO, MN and NJ
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 76890This product is part of a recall event; the main page for the event is Estriol Micronized, USP, Bulk recalled by Qinhuangdao Zizhu.