Why it was recalled
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'
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 63629-9207-1.
Lot numbers, UPCs & expiration codes
Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0540-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 10, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- 61 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack, Inc.
Original FDA data
Every field from FDA enforcement report D-0540-2024, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94605
- Address
- 1919 N Victory Pl
- Code information
- Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
- Postal code
- 91504-3425
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0540-2024
- Classification
- Class III
- Recalling firm
- Bryant Ranch Prepack, Inc.
- Product quantity
- 61 Bottles
- 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'
- Voluntary / mandated
- Voluntary: Firm initiated
- 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 63629-9207-1.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2024