Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cepha...
FDA Recall #D-0538-2024 — Class III — May 10, 2024
Product Description
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.
Reason for Recall
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Recalling Firm
Bryant Ranch Prepack, Inc. — Burbank, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
104 bottles
Distribution
Nationwide in the USA
Code Information
Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated