The Recall Desk

FDA (Drugs) recall action 80097

Lupin Pharmaceuticals Inc. recalled 2 products on 2018-05-30

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-05-30
Critical
0
Units
87,562

Why these products were recalled

Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2018-05-30

    Lupin Recalls My Way Emergency Contraception Tablets for Lack of Approval

    Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-05-30

    Lupin Recalls My Way Levonorgestrel Tablets for Lack of Approved NDA

    Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.

    Product
    My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180…
    Category
    Distribution
    0 states