Why it was recalled
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Product description
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.
Lot numbers, UPCs & expiration codes
a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.
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-0256-2022
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 28, 2021
- FDA report date
- Dec 1, 2021
- Quantity
- 119 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0256-2022, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 88847
- Address
- 1919 N Victory Pl
- Code information
- a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.
- Postal code
- 91504-3425
- Report date
- Dec 1, 2021
- Product type
- Drugs
- Recall number
- D-0256-2022
- Classification
- Class III
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Product quantity
- 119 Bottles
- Reason for recall
- Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 28, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2021