D-0538-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 12, 2024
- Initiation Date
- May 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 bottles
Product Description
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.
Reason for Recall
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'
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;