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.
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 due to CGMP deficiencies and odor complaints, which typically indicate a risk of temporary or medically reversible adverse health consequences or are remote risks of serious adverse health consequences.
Plain-English summary
Marksans Pharma Inc. is recalling 52,549,000 Ibuprofen Tablets, USP 800 mg, due to complaints of odor related to Current Good Manufacturing Practice (CGMP) deficiencies. The recalled product consists of bulk-packed tablets intended for further packaging by repackaging firms.
The affected tablets were distributed to repackaging firms in New York, which then distributed the product nationwide in the United States. The recall covers specific lots with expiration dates ranging from February 2018 to September 2018.
Consumers and healthcare providers should stop using the recalled ibuprofen tablets and return them to the pharmacy or point of purchase for a refund or replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Marksans Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 52,549,000
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 #: Lot #: HM6067
- HM6068
- HM6069
- HM6070
- HM6072
- HM6073
- HM6074
- HM6075
- HM6076
- HM6077
- HM6078
- HM6079
- HM6080
- HM6081
- HM6082
- HM6083
- HM6084
- HM6085
- HM6086
- HM6087
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
Same manufacturer · Marksans Pharma Inc.
See all →- ModerateIbuprofen Tablets Recalled by FDA Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-01-31
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- ModerateMarksans Pharma Recalls Ibuprofen Tablets Due to Odor Complaints
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