Recalls / Class II

Class IID-0787-2023

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

Affected lot / code info

All Lots

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Recalling firm

Firm

Akorn, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278

Distribution

Quantity

N/A

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2023-04-26

FDA classified

2023-06-01

Posted by FDA

2023-06-07

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0787-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.