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.
Recall initiated: 20210521
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated