VistaPharm, Inc. recalls Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups
Recalled July 18, 2012 · FDA recall D-1416-2012 · VistaPharm
Hazard
Impurities/Degradation Products: exceeded specification at 3 month stability testing · FDA Class II
Units
a) 949 Cases, b) 188 bottles
Sold at
Nationwide
Description
Impurities/Degradation Products: exceeded specification at 3 month stability testing
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.
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →