Product: 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.
Reason for recall: Impurities/Degradation Products: exceeded specification at 3 month stability testing
Recall initiated: 20120530
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated