Enforcement Report - Week of July 18, 2012
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Event Detail
| Event ID | 62405 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | VistaPharm, Inc. |
| City | Largo |
| State | FL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13. | Class II | Impurities/Degradation Products: exceeded specification at 3 month stability testing | a) 949 Cases, b) 188 bottles | D-1416-2012 |
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