FDA recall D-0637-2021

Hill Dermaceuticals, Inc. · Class II · drug

Product

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20

Reason for recall

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-05-21
Report date: 2021-06-30
Termination date: 2022-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2021