FDA Recall D-0539-2024

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 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.

Lot / code: Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, Exp: 12/31/2025.

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'

Recall record

Recall number: D-0539-2024
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): 63629-9206
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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