FDA Drug Low Class III Ongoing

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.

Reported: June 12, 2024 Initiated: May 10, 2024 #D-0539-2024

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.

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'

Details

Recalling Firm: Bryant Ranch Prepack, Inc.
Units Affected: 190 bottles
Distribution: Nationwide in the USA
Location: Burbank, CA

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Bryant Ranch Prepack, Inc.. Units affected: 190 bottles.

Why was this product recalled? ▼

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'

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 12, 2024. Severity: Low. Recall number: D-0539-2024.

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