Drug recall D-0326-2024

Class II Ongoing reported Feb 28, 2024

Product

Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1

Reason for recall

CGMP Deviations: potential presence of Burkholderia cepacia complex

Lots and codes

Lot number # TX5274 Exp. 09/30/2026

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
292,752 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 9, 2024

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