Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ra...
FDA Recall #D-0536-2024 — Class III — May 10, 2024
Product Description
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Reason for Recall
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Recalling Firm
Bryant Ranch Prepack, Inc. — Burbank, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
156 bottles
Distribution
Nationwide in the USA
Code Information
Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated