Recalls / Class III
Class IIID-0539-2024
Product
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (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 63629-9206-1.
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDC
- 63629-9206
- FDA application
- ANDA210221
- Affected lot / code info
- Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, Exp: 12/31/2025.
Why it was recalled
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label 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
- 190 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-0539-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.