Drug Enforcement D-0538-2024

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'

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, 250mg/ 5mL, Rx only, 200mL (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 63629-8858-1.
Product quantity
104 bottles
Reason for recall
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'
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-0538-2024
Event ID
94605
Recall initiation date
May 10, 2024
Center classification date
June 4, 2024
Code info
Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;
More code info
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