FDAMay 21, 2021drug
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
What to do
FDA enforcement status: Terminated
Brands named
hill dermaceuticalshill
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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