← FDA ENFORCEMENT
D-0538-2024Class III

Bryant Ranch Prepack, Inc.

Recalling firm
Bryant Ranch Prepack, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-06-12
Distribution
Nationwide in the USA
Firm state
CA
Product quantity
104 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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'

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.