- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionPotential Inaccuracy of Latex Free Label Reference
- Company Name:
- Avella Specialty Pharmacy
- Brand Name:
Brand Name(s)Advanced Pharma
- Product Description:
Product DescriptionAll unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location
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 rare, 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.