The Recall Desk
LowFDA (Drugs)·D-0295-2016·Announced 2015-11-25

Akorn Recalls Hydrocortisone Otic Solution Due to Missing Safety Seal

Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the safety seal around the neck.

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. The issue is a packaging defect (missing seal) rather than a direct contamination or chemical hazard.

Plain-English summary

Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution, USP. The affected product is a prescription-only medication containing hydrocortisone (1%) and acetic acid (2%) in 10 mL bottles. The specific lot number is 346191, with an expiration date of 12/2016. The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the bottles are missing the safety seal around the neck. The product label explicitly states, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing this approved component and is not consistent with its labeling, the lot is being recalled.

Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if the safety seal is missing. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic/ENT
Hazard
Affected units
13,896

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 (2)

  • Lot # 346191
  • Exp. 12/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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