September 22, 2023
The following lot of Allergenic Extract – Pecan nut (Carya illinoinensis) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. has been voluntarily withdrawn by the manufacturer due to increased postmarketing adverse event reporting of false negative skin test results, with one case reported of life-threatening anaphylaxis from subsequent pecan nut exposure.
|Product Lot||Vial Volume||Concentration||Date of voluntary lot withdrawal||Expiration Date|
|0003963971||5 mL||1:10 5STV||31-Aug-2023||4-Feb-2024|
- Please examine your stock immediately to determine if you have any vials from this lot.
- If you have product from this lot, please cease use immediately.
- Contact the manufacturer’s Sales Support Department at 800-325-7354 to return the affected product and to receive replacement product.
Earlier in 2023, the FDA required (January 2023) and approved (February 2023) safety labeling changes to the Prescribing Information for all allergenic extracts for the diagnosis of food allergy, to include the following language in the Warnings or Warnings and Precautions section:
Anaphylaxis Following False Negative Food Allergen Skin Test Results
False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and the index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.
To report adverse events or product problems for any allergenic extract, contact the manufacturer or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch or via fax at 1-800-FDA-0718. Please include lot number in the report.