FDA recall D-1172-2022

Akorn, Inc. · Class II · drug

Product

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

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2022-06-13
Report date: 2022-07-06
Termination date: 2024-07-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2022