Alymsys FDA Alerts

Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab

August 30, 2019 -- 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 amargio@amexpharmacy.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). 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 amargio@amexpharmacy.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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System

April 29, 2019 -- AmEx Pharmacy is voluntarily recalling one Lot of Bevacizumab 1.25mg/0.05mL 31G Injectable to the consumer/user level. The Monoject Syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient.

The additional force needed to express the drug product could potentially result in damage to the eye while the needle is in the eye. To date, AmEx Pharmacy has received three reports associated with the Lot being recalled as either being difficult to express, two of which, resulted in an Adverse Drug Event.

The product 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. The affected Lot ofBevacizumab 1.25mg/0.05m 3 lG Injectable is 190212AB, BUD 5/13/2019. The product can be identified by referencing the Lot number 190212AB, which prominently appears on all labeling. This specific Lot was distributed nationwide to ophthalmologist clinics in the following states: PA, IL, TX, WI, KS, TN, IN, & AZ.

AmEx Pharmacy is notifying its consignees by telephone and overnight mail and is arranging for return/replacement of all recalled product. Administering physicians that have product which is being recalled should stop use, remove from inventory and return to AmEx Pharmacy.

Consumers with questions regarding this recall can contact AmEx Pharmacy at (800) 644 - 9431 or by email at pharmacist@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. - 6:00p.m, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to being administered this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

[Posted 08/18/2017]

ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
 
BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.

RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.

Health care professionals  are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[08/18/2017- Press Release - Bella Pharmaceuticals]

Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor

ISSUE: Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall. 

BACKGROUND: Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product label and corresponding medication name and lot number (see firm press release for lot numbers).

RECOMMENDATION: Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and healthcare providers with questions regarding this recall can contact Avella at (877) 738-0797 Monday through Friday between 6am and 6pm Pacific Standard Time or via e-mail at QA@avella.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/09/2013 - Firm Press Release - Avella Specialty Pharmacy]

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).  Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.

RECOMMENDATION: Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA.  The products should be retained and securely stored until further notice by the FDA.

FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or  
Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
Email - DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/03/2012 - Drug Integrity and Supply Chain Security Statement - FDA]

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. 

BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017  

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.

 
RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

• Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178