Voluntary Lot Withdrawals of Allergenic Extract – Peanut (Arachis hypogaea)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
December 20, 2022
The following lots of Allergenic Extract – Peanut (Arachis hypogaea) - For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. have been voluntarily withdrawn by the manufacturer due to increased postmarketing adverse event reporting of false negative skin test results, with some cases reported of life-threatening anaphylaxis from subsequent peanut exposure.
| Product Lot | Vial Volume | Concentration | Date of voluntary lot withdrawal | Expiration Date |
|---|---|---|---|---|
| 0004014634 | 5 mL | 1:10 w/v | 7-Nov-2022 | 7-Apr-2024 |
| 0004014635 | 10 mL | 1:10 w/v | 7-Nov-2022 | 7-Apr-2024 |
| 0004218744 | 5 mL | 1:10 w/v | 12-Dec-2022 | 8-Feb-2025 |
| 0004218745 | 10 mL | 1:10 w/v | 12-Dec-2022 | 8-Feb-2025 |
- Please examine your stock immediately to determine if you have any vials from these lots.
- If you have product from these lots, 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.
As with all non-standardized allergenic extracts, no U.S. standard of potency exists for this product. Since there are no specifications for the peanut allergen content of non-standardized peanut allergenic extracts, negative testing should be considered carefully in context. Based on the patient’s clinical history and the index of suspicion, healthcare providers may wish to confirm negative skin testing with serologic testing for peanut-specific IgE or a medically-supervised oral food challenge. 1
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. Please include lot number in the report.
1 Greenhawt M, Shaker M, Wang J, Oppenheimer JJ, Sicherer S, Keet C, Swaggart K, Rank M, Portnoy JM, Bernstein J, Chu DK, Dinakar C, Golden D, Horner C, Lang DM, Lang ES, Khan DA, Lieberman J, Stukus D, Wallace D. Peanut allergy diagnosis: A 2020 practice parameter update, systematic review, and GRADE analysis. J Allergy Clin Immunol. 2020 Dec;146(6):1302-1334. doi: 10.1016/j.jaci.2020.07.031. Epub 2020 Aug 15. PMID: 32810515.