Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Control
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