Avella Specialty Pharmacy Recalls Unexpired Sterile Injectable Products Labeled “Latex Free” Products May Contain Synthetic or Natural Latex

Late last week, the FDA announced 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 the “latex free” label statements are accurate in all cases. The risk of potential adverse events related to a latex allergy, while rare, can range from local site reactions, including swelling and inflammation, to allergic reactions that could be life-threatening to users who are sensitive to latex.

These products were distributed directly to healthcare facilities.

Customers in AL, AZ, CA, CO, CT, DE, FL, GA, MS, NC, NJ, OH, OK, OR, PA, SC, TN, TX, UT, or VA who 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 may 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.

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.fda.gov/MedWatch/report.
  • Download the 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.

If you need assistance, please contact Allison Madson, manager of regulatory affairs at amadson@ascrs.org or 703-591-2220.