Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Lupin Pharmaceuticals Inc.

NDC code

68180-405-01

Origin

MD, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0274-2024

Other Cefixime recalls

See all

Class II · Moderate risk Terminated Aug 21, 2024

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore…

Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-405-01 D-0648-2024

Class II · Moderate risk Terminated May 30, 2024

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin…

Reason Failed Content Uniformity Specifications

Lupin Pharmaceuticals Inc. NDC 68180-407-03 D-0559-2024

Class II · Moderate risk Terminated Dec 29, 2021

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…

Reason Failed Impurities/Degradation Specifications

RemedyRepack Inc. NDC 70518-2749-02 D-0360-2022

Class II · Moderate risk Terminated Dec 21, 2021

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by…

Reason Failed impurities/degradation specifications

Ascend Laboratories, LLC NDC 67877-584-50 D-0359-2022

Class II · Moderate risk Terminated Nov 3, 2021

Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India…

Reason Failed Impurities/Degradation Specifications

Ascend Laboratories LLC NDC 67877-584-50 D-0229-2022