Cefixime Capsules 400 mg Recalled for Failed Impurities and Degradation Specifications
Ascend Laboratories LLC is recalling Cefixime Capsules 400 mg nationwide due to failed impurities and degradation specifications. The affected lot is Lot 20140282 with an expiration date of December 2021.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text indicates an FDA Class II recall with no reported illnesses or injuries. The hazard involves failed quality specifications (impurities and degradation) rather than a known pathogen or documented harm, making this a moderate precautionary recall.
Plain-English summary
Ascend Laboratories LLC is recalling Cefixime Capsules 400 mg (NDC 67877-584-50) manufactured by Alken Laboratories Ltd., Mumbai, India. A total of 4,104 bottles have been distributed nationwide.
The recall is due to failed impurities and degradation specifications. The affected lot is Lot 20140282 with an expiration date of December 2021.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without consulting their doctor.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Ascend Laboratories LLC
- Affected units
- 4,104
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 20140282
- exp Dec 2021
Distribution
Distributed nationwide across the United States.
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