Drug Enforcement D-0536-2024

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'

Status

Ongoing

Classification

Class III

Report Date

June 12, 2024

Termination Date

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Product Information

Product description
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Product quantity
156 bottles
Reason for recall
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'
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Bryant Ranch Prepack, Inc.
Address
1919 N Victory Pl, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0536-2024
Event ID
94605
Recall initiation date
May 10, 2024
Center classification date
June 4, 2024
Code info
Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
More code info
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