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Enews Now
June 2018

Be Aware of the Fluticasone Propionate Nasal Spray Recall and Shortage of Sterile Water for Injection

Apotex Corp. Recalls Fluticasone Propionate Nasal Sprays over Glass Particle Concerns

Apotex Corp. is voluntarily recalling one lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The nasal spray has been found to contain small glass particles which could block the actuator and impact the functionality of the pump.

There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product. To date, Apotex Corp. has not received any reports of adverse events related to recall.

Visit the Food and Drug Administration's (FDA) website for further information on how to identify the affected lot.

Genentech Addresses the Shortage of Sterile Water for Injection

The leadership of the AAAAI and ACAAI have continued to monitor the shortage of Sterile Water for Injection (SWFI). Recently, Genentech sent a communication explaining they will begin importing 5 mL ampules of SWFI from Germany.

They are offering a limited supply of these imported SWFI ampules for free, which you can order by calling Genentech customer service at 1-800-551-2231.

Typically, SWFI in the U.S. comes in vials. The dosage and administration instructions provided in the FDA package inserts of the drug being reconstituted should be followed when using the ampules. Additional tips are also included in the letter from Genentech.

Any medical questions regarding the use of the 5 mL SWFI ampules should be addressed to Genentech medical communications at 1-800-821-8590. Complaints about the imported 5 mL ampules should be passed along to Genentech product quality at 1-800-334-0290. Adverse events may be reported to Genentech at 1-888-835-2555 or the FDA’s MedWatch Adverse Event Reporting System.

Please refer to the FDA Drug Shortage website for additional information on the sterile water shortage.