PlainRecalls
FDA Drug Moderate Class II Terminated

Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

Reported: January 3, 2024 Initiated: January 26, 2022 #D-0182-2024

Product Description

Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Details

Recalling Firm
CARDINAL HEALTHCARE
Units Affected
6 units
Distribution
Nationwide USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1. Recalled by CARDINAL HEALTHCARE. Units affected: 6 units.
Why was this product recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0182-2024.