Class II · Moderate risk Ongoing
MY CHOICE LEVONORGESTREL TABLET distributed to specific Family…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
My Way
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
What was recalled
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0837-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Levonorgestrel recalls
See all
Class II · Moderate risk Terminated
Lillow
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets USP
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class II · Moderate risk Terminated
Fayosim
Reason 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 Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Reason Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
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