#Endo pharmaceuticals headquarters download#

#Endo pharmaceuticals headquarters download#

Regular Mail or Fax: Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.

Complete and submit the report Online:.

Īdverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax. Additional information regarding this recall can be found at. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. EST Monday through Thursday and 8:00 a.m. If you have any questions regarding this recall, please call 1-800-462-ENDO (3636), between the hours of 8:00 a.m. Pharmacies and wholesalers that received lot number 207386 will receive a letter as well as a copy of this press release with their recall notification information.Įndo takes this issue seriously and is fully committed to ensuring all of its products and packaging meet the highest quality standards. Pharmacists who have dispensed impacted product are asked to notify their patients of this recall. EST) or via e-mail at for instructions on product return. Pharmacists and wholesalers are asked to check their inventories for lot number 207386, segregate any impacted inventory and contact Inmar at extension #1 at 1-80, Monday through Friday (9 a.m. Winston Salem, NC 27101-Attention Recall Department, Edex Recall.

Proof of purchase can be sent to or 635 Vine St.

Upon contacting Inmar, please be prepared to share proof of purchase.

Upon contacting Inmar and indicating you have unused product, please expect Return Authorization labels and Shipping instructions.

Please 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.