RxFormulations is Arizona's premier compounding pharmacy, meeting individual patient needs through custom compounding.
Our office hours are 8:00am-5:00pm Monday through Friday
Phone: 480.854.3100 Fax: 480.854.3156
FOR IMMEDIATE RELEASE- December 26, 2013 - Mesa, AZ Rx Formulations is voluntarily recalling Vitamin B-12 injections compounded with a Beyond Use Date after December 26, 2013 due to a lack of sterility assurance.
If a product intended to be sterile is contaminated and administered to patients, it may result in serious infections, which may be life-threatening. Rx Formulations has not received any reports of adverse events related to recall.
The product is used in patients with a vitamin B-12 deficiency and is packaged in individual dose prescription vials. The affected products will have been compounded before December 26, 2013 and contain a beyond use date after December 26, 2013. The product can be identified by Rx Formulations pharmacy prescription label with the pharmacy and patient name attached. This product distributed locally to approximately 4 individual prescription patients.
Rx Formulations is notifying these patients/customers by individual letter and phone calls and is arranging for return of all recalled products. Anyone who has sterile compound product which is being recalled should stop using and return to Rx Formulations.
Consumers with questions regarding this recall can contact Rx Formulations by phone 480.854.3100 or email firstname.lastname@example.org at any time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Important Recall Notice
Always conscious of our high standards of quality, we have recently issued a RECALL of a limited number of compounded products provided to some Banner Health facilities. Working with the Food and Drug Administration and with Banner Health we have sent a letter to Banner Health recalling products made on one of our eight Class 5 Hoods. We are having the Hood re-certified and will not use it until that is completed. To read the letter we sent to Banner Health please click here. While we cannot say at this point that any contamination came from Rx Formulations, we took no chances. We immediately recalled the products shown in the letter.
MedWatch is an important part of quality pharmacy practice. Please see the FDA statement below.
“FDA asks health care providers and consumers to report any adverse events that are associated with the use of any of these products to either Rx Formulations (480-854-3100) or to the FDA’s MedWatch Adverse Event Reporting program by:
• Downloading and completing the form , then submitting it via fax at 1-800-FDA-0178.”