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.

Recall Number: D-1411-2012

Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Classification: Class III

Status: Terminated

Report Date: 20120718

Initiation Date: 20120706

Termination Date: 20130201

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

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.