Hill Dermaceuticals, Inc. recalls DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals,…
- Recall date
- May 21, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0637-2021
- FDA classification
- Class II
- Brand / firm
- Hill Dermaceuticals, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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