Drug product
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.
D-0536-2024
Product summary
- Event
- Event 94605
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 156 bottles
- Official record key
drug-enforcement:D-0536-2024
Official wording
Reason: 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'
Code information: Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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'