Product: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Reason for recall: Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Recall initiated: 20191216
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated