← FDA ENFORCEMENT
D-0536-2024Class 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
156 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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'

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.

Code / lot info

Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025

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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.