Drug product
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
D-1037-2017
Product summary
- Event
- Event 77732
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 (5mL) unit dose cups
- Official record key
drug-enforcement:D-1037-2017
Official wording
Reason: Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Code information: Lot #: 500326, Exp. 6/30/2018
Distribution pattern: OH and CT
Derived failure modes
-
Labeling or packaging
Labeling Error: Label mix-up