FDA Drug recall D-0637-2021
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc by Hill Dermaceuticals, citing presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0637-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-21 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hill Dermaceuticals |
| Distribution | US |
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
Reason
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Identifiers
| ndc | 68791-103-20 |
|---|---|
| code_info | Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0637-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.