FDAFDA · Food and drugs·Recall number D-0837-2018
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.
Published May 30, 2018 · Recall initiated: May 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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