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  4. Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference
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COMPANY ANNOUNCEMENT

Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference

Summary

Company Announcement Date:
February 23, 2017
FDA Publish Date:
February 06, 2018
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Potential Inaccuracy of Latex Free Label Reference
Company Name:
Avella Specialty Pharmacy
Brand Name:
Brand Name(s)
Advanced Pharma
Product Description:
Product Description
All unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location

Company Announcement

Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products may contain synthetic latex and/or natural latex.

Avella and Advanced Pharma have been unable to confirm with clarity whether its “latex free” label statements are accurate in all cases and are therefore conducting this recall in an abundance of caution. The risk of potential adverse events related to a latex allergy, while raredisclaimer icon, can range from local site reactions including swelling and inflammation to allergic reactions which could be life-threatening to users who are sensitive to latex. These products were not distributed directly to patients or consumers, but rather to healthcare facilities (hospitals and institutions).

Avella Specialty Pharmacy is committed to patient safety in all instances and is therefore issuing this recall in an abundance of caution, although certain of the products subject to this voluntary recall may in fact be devoid of synthetic and/or natural latex. The issue is segregated to the Houston location and no other Avella Specialty Pharmacy locations. To date, no reported adverse events or patient safety issues have been reported as a result of the “latex free” labeling.

Avella Specialty Pharmacy is notifying customers of the voluntary recall by phone and mail. Customers in AL, AZ, CA, CO, CT, DE, FL, GA, MS, NC, NJ, OH, OK, OR, PA, SC, TN, TX, UT, or VA that have any of the affected medications labeled with “latex free” that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy. For a full list of Advanced Pharma products, please visit www.AdvancedPharma.com.

Patients and healthcare providers with questions regarding this recall can contact the Advanced Pharma recall line at (877) 292-4323, Monday through Friday, between 6am and 6pm Pacific Standard Time or via e-mail at ProductRecall@avella.com. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

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.

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


Company Contact Information

Consumers:
Advanced Pharma, Inc., d/b/a Avella of Houston
877-292-4323
ProductRecall@avella.com
Media:
Maureen Shanahan
mshanahan@skdknick.com

Product Photos