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

Recall Number: D-0637-2021

Firm: Hill Dermaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20210630

Initiation Date: 20210521

Termination Date: 20220928

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

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