Oral Contraceptive and Fluticasone Recalls

Go to the profile of Lee C. Vermeulen
Jun 04, 2018
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Two important medication recalls were announced last week.

On May 31, 2018, Apotex Corporation voluntarily recalled one lot of fluticasone propionate nasal spray 50 mcg/spray, 120 metered spray package size, to the consumer level.  The product has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. There is also the potential for patients to be exposed to the glass particles and suffer mucosal irritation as result. To date, the manufacturer has not received any reports of adverse events related to recall.  Note, while this recall is for a prescription-only product, there are OTC fluticasone nasal spray products also available.

Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately.  More information on how to respond to the recall can be found at the FDA web site using the link below.

On May 29, 2018, Allergan also voluntarily recalled a single lot of almost 170,000 physician sample packs of their norethindrone acetate and ethinyl estradiol capsules (Taytulla) due to the incorrect placement of placebo capsules in the pack.  The inactive placebo capsules were placed at the start of the 4-week blister pack instead of at the end, which could result in patients taking inactive non-hormonal doses when active drug is needed to prevent pregnancy, heightening the risk of unwanted pregnancy.  

The packs are marked with the lot number 5620706 and carry a May 2019 expiration date.  Allegan is notifying customers by recall letter, but since these products were distributed as samples by physicians (where record keeping is typically superficial) it is unlikely that such a campaign to the consumer will notify all affected patients.  Significant media attention has been paid to this recall, and health care providers should be aware of the concern.  Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.  More information on how to respond to the recall can be found at the FDA web site using the link below.

Additional information about fluticasone nasal spray and oral contraceptives can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.



FDA Announcement Regarding Fluticasone Recall:

https://www.fda.gov/Safety/Recalls/ucm609436.htm

FDA Announcement Regarding Oral Contraceptive Recall:
https://www.fda.gov/Safety/Recalls/ucm609044.htm

Go to the profile of Lee C. Vermeulen

Lee C. Vermeulen

Professor of Medicine and Pharmacy, University of Kentucky

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