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.
Reason for recall: Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Recall initiated: 20120706
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated