Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityv

Recalled March 27, 2019 · FDA recall D-1011-2019 · Akorn

Hazard

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. · FDA Class II

Units

15,322 10 ml bottles

Sold at

Nationwide USA and Puerto Rico

Description

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

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

Manufacturer(s)

Akorn Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →