Drug product
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
D-1139-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 77998
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3084 bottles
- Official record key
drug-enforcement:D-1139-2017
Official wording
Reason: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Code information: Lot: 494700 Exp. 10/2018
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
incorrectly labeled