Bryant Ranch Prepack, Inc.: Drug Recall

Recall Details

Recall Number

D-0539-2024

Classification

Class III

Product Type

Drug

Recalling Firm

Bryant Ranch Prepack, Inc.

Status

Ongoing

Date Initiated

05/10/2024

Location

Burbank, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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'

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Bryant Ranch Prepack, Inc.

• Class III: Low Risk 05/10/2024
  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
• Class III: Low Risk 05/10/2024
  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'
• Class III: Low Risk 05/10/2024
  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'
• Class III: Low Risk 05/10/2024
  Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
• Class III: Low Risk 04/20/2023
  Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

View all recalls by Bryant Ranch Prepack, Inc. →