Recalls / Class III
Class IIID-0537-2024
Product
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDC
- 63629-9205
- FDA application
- ANDA210221
- Affected lot / code info
- Lot:234892, Exp:02/28/2025.
Why it was recalled
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
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
- 6 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-0537-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.