The Recall Desk

FDA (Drugs) recall action 78822

Marksans Pharma Inc. recalled 6 products on 2018-01-31

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-01-31
Critical
0
Units
309,291,000

Why these products were recalled

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

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.

States named across these recalls

1–6 of 6

  • ModerateFDA (Drugs)··2018-01-31

    Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling 4,127,500 ibuprofen tablets due to odor complaints and CGMP deficiencies. The product was distributed nationwide to repackaging firms.

    Product
    Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-01-31

    Marksans Pharma Recalls Ibuprofen Tablets Due to Odor Complaints

    Marksans Pharma Inc. is recalling 21,584,100 Ibuprofen Tablets, USP 400 mg, due to odor complaints linked to CGMP deficiencies.

    Product
    Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-01-31

    Ibuprofen Tablets Recalled for Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling 52,549,000 ibuprofen tablets due to odor complaints and CGMP deficiencies. The product was distributed nationwide.

    Product
    Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-01-31

    Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling specific lots of 600 mg ibuprofen tablets due to odor complaints linked to CGMP deficiencies.

    Product
    Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
    Category
    Distribution
    1 state