Lupin Recalls Cefixime Oral Suspension Due to Low Potency
Lupin Pharmaceuticals is recalling 4,518 bottles of Cefixime for Oral Suspension because a stability study showed the drug was below the required strength.
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. The hazard is a subpotent drug (low potency), which is a quality issue that may result in treatment failure but does not involve acute toxicity or reported injuries, fitting the Moderate severity criteria for low-risk contamination or quality defects.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 4,518 bottles of Cefixime for Oral Suspension USP, 100mg/5mL. The recall is due to a low out-of-specification test result observed in a long-term stability study, indicating the medication may be subpotent.
The affected product is identified by Lot # F800779 with an expiration date of 4/2020. It was distributed nationwide in the United States and Puerto Rico. The product is a prescription-only medication manufactured for Lupin Pharmaceutical, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in India.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 4,518
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 (2)
- Lot #: F800779
- Expiry 4/2020
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
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