The Recall Desk
ModerateFDA (Drugs)·D-0239-2018·Announced 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.

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 the hazard involves odor complaints related to CGMP deficiencies without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Marksans Pharma Inc. is recalling 23,088,900 tablets of Ibuprofen Tablets, USP 600 mg, NDC 25000-122-28. The affected product is bulk packed in double polybag shipper packs for further packaging and is prescription-only. The recall involves specific lots with expiration dates ranging from March 2018 to September 2018.

The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The product was distributed to repackaging firms in New York, which then distributed the product nationwide in the USA.

Consumers and healthcare providers should stop using the affected lots and return them to the source of purchase or contact the recalling firm for instructions.

The recalled product

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.
Manufacturer
Marksans Pharma Inc.
Category
Drug — Tablets
Hazard
Affected units
23,088,900

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 (20)

  • Lot #: HN6004
  • HN6005
  • HN6006
  • HN6007
  • HN6008
  • HN6009
  • HN6010
  • HN6011
  • HN6012
  • HN6013
  • HN6014
  • Exp 03/18
  • HN6015
  • HN6016
  • HN6017
  • HN6018
  • HN6019
  • HN6020
  • HN6021
  • HN6022

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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