D-0536-2024 Class III Ongoing
FDA drug recall D-0536-2024 was initiated by Bryant Ranch Prepack, Inc. on May 10, 2024 and is designated Class III. Reason for recall: 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… The recall status is ongoing. Affected quantity: 156 bottles.
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
- 156 bottles
Product Description
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.
Reason for Recall
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'
Distribution Pattern
Nationwide in the USA
Code Information
Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025