VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles
Recalled February 8, 2017 · FDA recall D-0458-2017 · VistaPharm
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. · FDA Class II
Units
32,027 bottles and 16,310 unit dose cups
Sold at
Nationwide
Description
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product
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
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →