Drug recall D-0539-2024

Class III Ongoing reported Jun 12, 2024

Product

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.

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'

Lots and codes

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.

Recall details

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

Related products