Ibuprofen Tablets Recalled for Odor Complaints and CGMP Deficiencies
Marksans Pharma Inc. is recalling ibuprofen tablets due to odor complaints linked to Current Good Manufacturing Practice (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 involves CGMP deficiencies leading to odor complaints, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injury.
Plain-English summary
Marksans Pharma Inc. is recalling Ibuprofen Tablets, USP 200 mg, in the form of 6 x 6500 caplets. The affected product is bulk packed in double polybag shipper packs for further packaging and is prescription only. The specific lots involved are HH6001 and HH6002, with an expiration date of 04/18.
The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The product was manufactured by Marksans Pharma Ltd. in India and distributed to repackaging firms in New York, which then distributed the product nationwide in the USA.
Consumers and healthcare providers should discontinue use of the affected lots and contact their pharmacist or the recalling firm for further instructions. The recall covers 2,853,500 caplets.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Marksans Pharma Inc.
- Category
- Drug — Ibuprofen Tablets
- Hazard
- Affected units
- 2,853,500
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 (3)
- Lot #: HH6001
- HH6002
- Exp 04/18
UPCs (9)
- 0325000114022
- 0325000117146
- 0325000114039
- 0325000117030
- 0325000117023
- 0325000114145
- 0325000117696
- 0325000114718
- 0325000114701
Distribution
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.
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