11/16/2023 0 Comments Fda request endo pharmaceuticalsPlease contact Inmar at 1-84, Monday through Friday (9am to 5pm EST) or email for the following:.Consumers who are unsure if they have the affected lot number should consult their pharmacist or health care professional.Ĭonsumers in possession of any unused prescribed Edex® 10 mcg product bearing lot number 207386 should immediately discontinue use of the product and return the unused product by following the instructions below: The lot number can be found on the manufacturer's unit. The affected lot was distributed from Decemthrough Februto wholesale distributors and retail pharmacies throughout the United States. The recall applies to the 10 mcg strength, packaged in a 2 pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019 (see photographs of packaged product within). To date, Endo has not received adverse event reports related to this recall.Įdex® (alprostadil for injection) is a prescription only intracavernous injection indicated for the treatment of male erectile dysfunction. 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 product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot. based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex® (alprostadil for injection) 10 mcg to the consumer level. Endo International plc (NASDAQ / TSX: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc.
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