FDA Recall Terminated Historical recordClass II
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
- Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
- Published
- June 30, 2021
- Distribution
- Nationwide
