Drug product
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (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 63629-9206-1.
D-0539-2024
Product summary
- Event
- Event 94605
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 190 bottles
- Official record key
drug-enforcement:D-0539-2024
Official wording
Reason: Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Code information: Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, 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' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'