FDA recall D-1011-2019

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.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-03-12

Report date

2019-03-27

Termination date

2022-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1011-2019