Class II
Terminated
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
- Company
- Hill Dermaceuticals, Inc.
- Recall Initiated
- May 21, 2021
- Posted
- June 30, 2021
- Recall Number
- D-0637-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 34,561 bottles for sale; 773 bottles for samples
- Firm Location
- Sanford, FL, United States
Reason for Recall
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Distribution
Nationwide within the United States
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
More recalls by Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manuf...
Apr 2, 2014 · Class III
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottl...
Nov 27, 2013 · Class III
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bot...
Jul 3, 2013 · Class III
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