FDA recall D-0536-2024

Product

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'

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-05-10

Report date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0536-2024