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Medication Safety Alerts

Edex® 10 mcg Injection Voluntary Recall

2/27/2017

On February 27, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of Edex® 10 mcg Injection packaged in a 2 pack carton (NDC 52244-0010-02) and manufactured by Endo International. This recall was issued because of a defect in the manufacturing process affecting the container closure. This defect could affect the product’s sterility which could cause infections. 

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 207386 exp. 05/19. To see if you have affected product, please check the lot number. The lot number is on the bottom flap of the manufacturer’s box and on the manufacturer’s label on the product. If your product is not from lot number 207386 it is not affected by this recall. If your product is from lot number 207386, please contact the pharmacy that filled your prescription for further instructions.

Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently using Edex 10 mcg Injection, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

For more information, please call Endo International toll-free at 1-800-462-ENDO (3636), Monday through Thursday, 8:00 am to 8:00 pm (ET) and Friday, 8:00 am to 6:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov/.

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