FDA Recall D-0538-2024

Bryant Ranch Prepack, Inc. · Burbank, CA

Class III Ongoing 734 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

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.

Lot / code: Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;

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 record

Recall number: D-0538-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-05-10
Classified by FDA Center: 2024-06-04
FDA published: 2024-06-12
Recalling firm: Bryant Ranch Prepack, Inc.
Firm location: Burbank, CA

Drug identification

Brand name(s): CEPHALEXIN
Generic name(s): CEPHALEXIN
Manufacturer(s): Bryant Ranch Prepack
NDC(s): 63629-8858
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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