Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues
Lupin Pharmaceuticals is recalling 46,479 bottles of Oseltamivir Phosphate oral suspension because out-of-specification test results were found for Impurity C during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 46,479 bottles of Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL. The product is a prescription medication manufactured by Lupin Limited in India and distributed nationwide in the United States. The specific lot affected is # A906423, with an expiration date of November 2021.
The recall was initiated due to failed impurities and degradation specifications. Specifically, out-of-specification test results were observed for Impurity C at the 9-month long-term stability time point. This indicates that the product did not meet the required quality standards for impurity levels during the stability testing period.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
- Brand
- OSELTAMIVIR PHOSPHATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 46,479
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 # A906423
- exp. date Nov 2021.
Distribution
Distributed nationwide across the United States.
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