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Drug Safety Alerts
Edex® 10 mcg Injection Consumer-Level Recall
02/27/2017
On February 27, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level 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 due to a defect in the crimp caps used in the manufacture of the subject product lot. This defect has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
This recall affects lot number 207386 exp. 05/19. The affected lot went into distribution on December 13, 2016. No other lots are affected by this issue.
CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Edex 10 mcg Injection to contact their prescriber.
For more information about this recall, health care providers may contact Endo International 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 contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at https://www.fda.gov/.