Recall: D-0537-2024

Class III - Minor Violations

Class IIIClassification

2024-05-10Initiated

OngoingStatus

Bryant Ranch Prepack, Inc.Firm

Product

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.

Reason

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.