FDA recall D-0839-2020

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.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-12-16

Report date

2020-02-19

Termination date

2022-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2020