FDA Recall Hydrocodone Bitartrate And Acetaminophen
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Hydrocodone Bitartrate And Acetaminophen with NDC 66689-023 was initiated on 08-17-2017 as a Class III recall due to labeling: not elsewhere classified; product is incorrectly labeled as class iii controlled substance instead of class ii controlled substance The latest recall number for this product is D-1139-2017 and the recall is currently terminated as of 03-11-2019 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1139-2017 | 08-17-2017 | 09-20-2017 | Class III | 3084 bottles | 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 | Terminated |
| D-0458-2017 | 01-18-2017 | 02-08-2017 | Class II | 32,027 bottles and 16,310 unit dose cups | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | Terminated |
| D-1416-2012 | 05-30-2012 | 07-18-2012 | Class II | a) 949 Cases, b) 188 bottles | Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.