The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0787-2023·Announced 2023-06-07

Azelastine Hydrochloride Nasal Spray Recalled Due to Manufacturing Deviations

Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray nationwide due to manufacturing process deviations. The firm ceased operations and could no longer conduct required stability studies.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is precautionary in nature, initiated because the manufacturer ceased operations and could not complete required stability studies, making this a voluntary precautionary recall.

Plain-English summary

Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray, 0.15% (105.5 mcg per spray), distributed nationwide in the USA and Puerto Rico. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.

The recalling firm went out of business and could no longer continue the stability studies required to verify the product's quality and safety. Without completion of these studies, the firm cannot demonstrate that the product maintains its intended strength and quality throughout its shelf life.

The recalled product

Product
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Nasal Spray
Hazard

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)

  • All Lots

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 86 recalled by Akorn, 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 86 products in this recall →

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