Recalls / Class II
Class IID-0637-2021
Product
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
- Brand name
- Dermotic
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Auricular (otic)
- NDC
- 68791-103
- FDA application
- NDA019452
- Affected lot / code info
- Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22
Why it was recalled
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Recalling firm
- Firm
- Hill Dermaceuticals, Inc.
- Manufacturer
- Royal Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2650 S Mellonville Ave, N/A, Sanford, Florida 32773-9311
Distribution
- Quantity
- 34,561 bottles for sale; 773 bottles for samples
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-05-21
- FDA classified
- 2021-06-23
- Posted by FDA
- 2021-06-30
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0637-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.