Recalls / Class III
Class IIID-0256-2022
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, Burbank, California 91504-3425
Distribution
- Quantity
- 119 Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-09-28
- FDA classified
- 2021-11-23
- Posted by FDA
- 2021-12-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0256-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.