The Recall Desk
LowFDA (Drugs)·D-1173-2014·Announced 2014-04-02

Hill Dermaceuticals Recalls Subpotent DermOtic Oil Ear Drops

Hill Dermaceuticals is recalling DermOtic Oil ear drops because the active ingredient was found to be subpotent during routine testing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Hill Dermaceuticals, Inc. is recalling DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottles. The recall involves 4,080 bottles with lot number 12H028B and an expiration date of 01/14. The product is prescription-only and was distributed nationwide and in Puerto Rico.

The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. This means the medication may not contain the full amount of the active ingredient required to be effective.

Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Manufacturer
Hill Dermaceuticals, Inc.
Category
Drug — Ophthalmic/Ear Drops
Hazard
Affected units
4,080

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 (1)

  • 12H028B exp. 01/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hill Dermaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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