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Recall Observatory FDA recall evidence

Drug 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.

D-0538-2024

May 10, 2024

Class III

Product summary

Firm
Bryant Ranch Prepack, Inc.
Event
Event 94605
Status
Ongoing
Classification
Class III
Quantity
104 bottles
Official record key
drug-enforcement:D-0538-2024

Official wording

Reason: 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'

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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'