Hill Dermaceuticals, Inc. recalls DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals
Recalled June 30, 2021 · FDA recall D-0637-2021 · Hill Dermaceuticals
Hazard
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. · FDA Class II
Units
34,561 bottles for sale; 773 bottles for samples
Sold at
Nationwide within the United States
Description
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
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
Manufacturer(s)
Hill Dermaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →