Drug recall D-0540-2024

Class III Ongoing reported Jun 12, 2024

Product

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 63629-9207-1.

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'

Lots and codes

Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025

Recall details

Recalling firm
Bryant Ranch Prepack, Inc., Burbank, CA
Quantity
61 Bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 10, 2024

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