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 63629-9207-1.
D-0540-2024
Product summary
- Event
- Event 94605
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 61 Bottles
- Official record key
drug-enforcement:D-0540-2024
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: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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'