The Recall Desk
ModerateFDA (Drugs)·D-0236-2018·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deficiencies related to odor complaints, which fits the criteria for a moderate severity recall without reported serious injuries or deaths.

Plain-English summary

Marksans Pharma Inc. is recalling 4,127,500 tablets of Ibuprofen Tablets, USP 200 mg. The recall is due to complaints of odor related to Current Good Manufacturing Practice (CGMP) deficiencies. The affected product is identified by Lot numbers HI6001, HI6002, and HI6003, with an expiration date of 02/18.

The recalled tablets were bulk packed in double polybag shipper packs for further packaging. They were distributed to repackaging firms in New York, which then distributed the product nationwide in the USA. The product is prescription-only.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II.

The recalled product

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.
Manufacturer
Marksans Pharma Inc.
Category
Drug — Tablets
Hazard
Affected units
4,127,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: HI6001
  • HI6002
  • HI6003
  • Exp 02/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Marksans Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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