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
Product summary
- 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
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'