FDA-Drug2021-06-30Class 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
Hill Dermaceuticals, Inc.
Hazard
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Sold states
Nationwide within the United States
Affected count
34,561 bottles for sale; 773 bottles for samples
Manufactured in
2650 S Mellonville Ave, N/A, Sanford, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2021Don't want to check this manually?
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