Cefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications
RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.
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: This is an FDA Class II recall involving a pharmaceutical product with impurities and degradation issues. The source text does not report any illnesses or hospitalizations, and the recall appears to be precautionary in nature based on quality specification failures detected during testing or inspection.
Plain-English summary
RemedyRepack Inc. is recalling Cefixime 400 mg capsules manufactured by Ascend Labs, LLC. The recall affects both 2-count bottles (NDC 70518-2749-02) and 2-count blister packs (NDC 70518-2749-03). The products were distributed to two direct accounts in Michigan and Pennsylvania.
The recall was issued because the affected products failed impurities and degradation specifications. This means the medication may contain unacceptable impurities or degradation byproducts that do not meet established quality standards for pharmaceutical products.
Multiple lot numbers are affected with varying expiration dates, including lots B1429436-110821, B1429434-110821, B1429435-110821, B1279449-072021, B1279457-072021, B1279442-072021, B1057718-012621, B1057727-012621, B1358139-092121, B1424654-110421, and B1437578-111421.
Patients should contact their healthcare provider or pharmacist if they have received this medication to determine appropriate next steps.
The recalled product
- Product
- Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antibiotic / Oral Capsule
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 #: a) B1429436-110821
- Exp 07/2022
- B1429434-110821
- Exp 11/2022
- B1429435-110821
- B1279449-072021
- B1279457-072021
- B1279442-072021
- B1057718-012621
- Exp 01/2022
- B1057727-012621
- b) B1358139-092121
- Exp 03/2022
- B1424654-110421
- B1437578-111421
- Exp 05/2022
Distribution
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