Drug recall
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg/15 mL; 50 x 15 mL unit dose cups per…
FDA recall event 51858 · Class II · VistaPharm, Inc.
Key facts
| Event ID | 51858 |
|---|---|
| Recall numbers | D-1883-2009 |
| Recalling firm | VistaPharm, Inc. |
| Product type | Drugs |
| Products | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg/15 mL; 50 x 15 mL unit dose cups per case; Rx only; Manufactured by VistaPharm Inc., Largo, FL 33771; 15 mL NDC 66689-021-01; 50 x… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | cGMP Deviations: This product was not manufactured under Current Good Manufacturing Practices. |
| Initiation date | Jan 29, 2009 |
| Termination date | May 12, 2010 |
| City | Largo |
| State | FL |
| Country | United States |
| FEI number | 1036352 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports