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.
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 aligns with the rubric for moderate severity involving minor labeling or quality issues without reported serious injury.
Plain-English summary
Marksans Pharma Inc. is recalling 21,584,100 Ibuprofen Tablets, USP 400 mg, which are bulk packed in double polybag shipper packs for further packaging. The affected product is prescription-only and was manufactured by Marksans Pharma Ltd. in India. The recall covers lots HK6001 through HK6015 with an expiration date of 09/18.
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 tablets nationwide in the United States.
Consumers and healthcare providers should stop using the affected ibuprofen tablets and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall is classified as Class II by the FDA.
The recalled product
- 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.
- Manufacturer
- Marksans Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 21,584,100
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 (16)
- Lot #: HK6001
- HK6002
- HK6003
- HK6004
- HK6005
- HK6006
- HK6007
- HK6008
- HK6009
- HK6010
- HK6011
- HK6012
- HK6013
- HK6014
- HK6015
- Exp 09/18
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.
See all 6 products in this recall →Related recalls
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