Lupin Pharmaceuticals Inc. recalls My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per…
- Recall date
- May 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0837-2018
- FDA classification
- Class II
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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.
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