Recalls / Class III
Class IIID-0536-2024
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.
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDC
- 63629-9204
- FDA application
- ANDA210221
- Affected lot / code info
- Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
Why it was recalled
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'
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc.
- Manufacturer
- Bryant Ranch Prepack
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- 156 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-05-10
- FDA classified
- 2024-06-04
- Posted by FDA
- 2024-06-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0536-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.