Class II · Moderate risk
MY CHOICE LEVONORGESTREL TABLET distributed to specific Family…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Levonorgestrel Non-Micronized
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; lack of quality assurance.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What 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),
Affected NDC
44132-0012-01
Compare with the code on your package — it is the most precise check available.
Drug: Levonorgestrel
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levonorgestrel NDC 44132-0012 |
1 kg/kg | Powder | Qinhuangdao Zizhu Pharmaceutical Co., Ltd. | BULK INGREDIENT |
- Recalling firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- NDC code
- 44132-012-01
- Origin
- N/A, China
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0660-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levonorgestrel recalls
See all
Class II · Moderate risk
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP)
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Levonorgestrel and Ethinyl Estradiol Tablets USP
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class II · Moderate risk
Fayosim (levonorgestrel and ethinyl estradiol)
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class III · Low risk
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Other recalls by Qinhuangdao Zizhu Pharmaceutical, Co.
All 2017 recalls
Class II · Moderate risk
Ethinyl Estradiol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Testosterone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
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