D-1172-2022 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-1172-2022 was initiated by Akorn, Inc. on Jun 13, 2022 and is designated Class II. Reason for recall: Defective container: defect prevents product from dispensing as intended. The recall status is terminated (terminated Jul 14, 2024). Affected quantity: 44,400 bottles.

Recall Details

Product Type
Drugs
Report Date
Jul 6, 2022
Initiation Date
Jun 13, 2022
Termination Date
Jul 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,400 bottles

Product Description

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

Reason for Recall

Defective container: defect prevents product from dispensing as intended.

Distribution Pattern

Nationwide USA

Code Information

Lot #: 379073, 379079, Exp 9/30/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1172-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.