Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityvill
Recalled February 19, 2020 · FDA recall D-0839-2020 · Akorn
Hazard
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. · FDA Class II
Units
16,078 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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.
Manufacturer(s)
Akorn Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →