Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: c...
FDA Recall #D-0537-2024 — Class III — May 10, 2024
Product Description
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
Reason for Recall
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Recalling Firm
Bryant Ranch Prepack, Inc. — Burbank, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
6 bottles
Distribution
Nationwide in the USA
Code Information
Lot:234892, Exp:02/28/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated