Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, U
Summary
The FDA issued a Class III for Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), by Bryant Ranch Prepack, Inc.. Reason: Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each.
Details
Source
Drug Recall
External ID
D-0539-2024
Action Date
2024-06-12
Status
Ongoing
Category
drug
Product Description
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (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 63629-9206-1.
Lot/Code Info: Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, Exp: 12/31/2025.
Quantity Affected: 190 bottles
Reason for Recall
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-10
Company
Burbank, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bryant Ranch Prepack, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bryant Ranch Prepack, Inc. have FDA actions?
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0539-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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