Dermotic Oil
FDA Recall NDC 68791-103
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dermotic (NDC 68791-103). A significant event, classified as Class II, was initiated on May 21, 2021 by Royal Pharmaceuticals. The reported reason for this action was: "Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
May 21, 2021
Jun 30, 2021
34,561 bottles for sale; 773 bottles for samples
Recall Profile & Regulatory Data
Event ID
87990
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hill Dermaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 28, 2022
Product Description
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
68791-103-20Product
Class III Terminated
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Apr 02, 2014
13,379 bottles
Recall Profile & Regulatory Data
Event ID
67420
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hill Dermaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 03, 2015
Product Description
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Batch or Lot Expiration Information
Lot# 13F015B exp. 12/14, 13G023B exp. 01/15
Affected Packages Involved in this Recall
68791-103-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
