The Recall Desk
HighFDA (Drugs)·D-0637-2021·Announced 2021-06-30

DermOtic fluocinolone acetonide ear drops recalled for broken glass risk

Hill Dermaceuticals is recalling DermOtic (fluocinolone acetonide) ear drops due to the potential for broken glass in the glass pipette dropper. The affected product was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II recall involving a potential injury hazard (broken glass in a dropper used in the ear canal) where no reported illnesses or injuries are stated in the source. The risk of harm is direct and significant, placing it in the High category per the rubric.

Plain-English summary

Hill Dermaceuticals, Inc. is recalling DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops, a prescription medication, due to the presence of a foreign substance: potential for broken glass within the glass pipette of the dropper.

The recalled product includes 34,561 bottles for sale and 773 bottles for samples, with specific lot numbers and expiration dates ranging from May 2021 through June 2022. The affected lots are: 19K036D, 19L039E; 20A001E, 20A003D, 20A003E; 20C013G; 20E025F, 20E025G, 20E025H; 20H041D, 20H041F; 20J043E; 20K050F; 20L055E; and 21C015E, 21C018E. Distribution was nationwide within the United States.

Consumers who have purchased this product should stop using it immediately and contact their healthcare provider or pharmacist for guidance. Those with questions may reach out to Hill Dermaceuticals or Royal Pharmaceuticals for additional information.

The recalled product

Product
DERMOTIC (FLUOCINOLONE ACETONIDE)
Brand
DERMOTIC
Manufacturer
Hill Dermaceuticals, Inc.
Category
Drug — Ear / Otic Drops
Hazard
  • broken-glass
  • foreign-substance
  • injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category