Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVIL
Recalled July 18, 2012 · FDA recall D-1411-2012 · Vintage Pharmaceuticals LLC
Hazard
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point. · FDA Class III
Units
54,431 bottles
Sold at
Nationwide and Puerto Rico.
Description
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Product
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Manufacturer(s)
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →