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'
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.
Lot numbers, UPCs & expiration codes
Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
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-0536-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 10, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- 156 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack, Inc.
Original FDA data
Every field from FDA enforcement report D-0536-2024, 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:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
- Postal code
- 91504-3425
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0536-2024
- Classification
- Class III
- Recalling firm
- Bryant Ranch Prepack, Inc.
- Product quantity
- 156 bottles
- 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'
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2024