Company Announcement Date: August 30, 2019
FDA Publish Date: August 30, 2019
Product Type: Drugs
Reason for Announcement: Potential for non-sterility
Company Name: Pacifico National, Inc. dba AmEx Pharmacy
Brand Name: AmEx Pharmacy
Product Description: Bevacizumab 1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable
AmEx Pharmacy today announces a voluntary recall of all Lots of Bevacizumab 1.25mg/0.05mL 31G Injectable and all Lots of Bevacizumab 2.5mg/0.1ml Normject TB Injectable that are within expiry to the healthcare provider level. These lots are being recalled out of an abundance of caution following an FDA inspection.
While all products associated with this voluntary recall passed compendial testing per USP 71 and USP 85, administration of a non-sterile drug product intended to be sterile may present the risk of infection.
The product involved in this recall is used for Wet Age-related Macular Degeneration and Diabetic Retinopathy. It is individually wrapped and labeled in a Tyvek pouch which is then placed in a labeled amber bag to protect from light. All Lots of Bevacizumab 1.25mg/0.05m 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable are subject to this voluntary recall. The product can be identified by referencing the Lot number which is prominently displayed on the amber bag and Tyvek pouch of the product. The specific Lots were distributed nationwide to ophthalmologist clinics in the following states: AR, AZ, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, WA, WI, WV, and PR.
AmEx Pharmacy is notifying its consignees by email and overnight mail and is arranging for return of all recalled product. Administering physicians that have product which is being voluntarily recalled should stop use, remove from inventory and return to AmEx Pharmacy. All Lots of unexpired Bevacizumab products distributed by AmEx Pharmacy are affected by this voluntary recall.
Consumers with questions regarding this recall can contact AmEx Pharmacy at (800) 644 – 9431 or by email at firstname.lastname@example.org during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to being administered this drug product.
Practitioners that have impacted product with these Lot numbers should contact AmEx Pharmacy at (800) 644-9431 or by email at email@example.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.