Drug 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.
D-0256-2022
Product summary
- Event
- Event 88847
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 119 Bottles
- Official record key
drug-enforcement:D-0256-2022
Official wording
Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label