Product: Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Reason for recall: Defective Container: Product missing safety seal around the neck of the bottle.  The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing."  Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Recall initiated: 20150821
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated