Cefixime for Oral Suspension USP recall

Why it was recalled

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

Details

Product

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Recalling company

Lupin Pharms

Classification

Class II

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

USA nationwide.

Initiated

Aug 21, 2024

FDA report date

Sep 4, 2024