Product: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701.  NDC: 50383-901-10
Reason for recall: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Recall initiated: 20190312
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated