Home / Recalls / Hill Dermaceuticals, Inc. / D-0637-2021

D-0637-2021 Class II Terminated

Recalled by Hill Dermaceuticals, Inc. — Sanford, FL

Recall Details

Product Type
Drugs
Report Date
June 30, 2021
Initiation Date
May 21, 2021
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,561 bottles for sale; 773 bottles for samples

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

Reason for Recall

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Distribution Pattern

Nationwide within the United States

Code 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

Other recalls by Hill Dermaceuticals, Inc.

  • D-1178-2014 Class III — ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 (January 31, 2014)
  • D-1175-2014 Class III — Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., (January 31, 2014)
  • D-1180-2014 Class III — SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl. (January 31, 2014)
  • D-1173-2014 Class III — DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Ma (January 31, 2014)
  • D-1174-2014 Class III — Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz. (January 31, 2014)
  • D-1176-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (January 31, 2014)
  • D-1177-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), (January 31, 2014)
  • D-1181-2014 Class III — SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx onl (January 31, 2014)
  • D-1179-2014 Class III — SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 f (January 31, 2014)
  • D-008-2014 Class III — Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 (September 8, 2013)