Edge Pharma Recalls Methacholine Challenge Test Kits Due to Storage Labeling Error
Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kits because they were labeled with incorrect room temperature storage conditions instead of the required refrigerated conditions.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Edge Pharma, LLC is recalling 213 kits of Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe. The affected products are identified by Lot # 12-2020-16@10 with a best-use date of 3-30-21 and Lot # 11-2020-18@11 with a best-use date of 3-02-21. The products were distributed nationwide in the US.
The recall was initiated because the products were labeled with incorrect room temperature (15-25 °C) storage conditions rather than the correct refrigerated (2 - 8 °C) storage conditions. This labeling error constitutes a temperature abuse issue for the sterile inhalation solution.
Consumers and healthcare providers should stop using the affected products and contact Edge Pharma, LLC for further instructions or a return. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Inhalation Solution
- Affected units
- 213
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 12-2020-16@10
- BUD 3-30-21 Lot # 11-2020-18@11
- BUD 3-02-21
Distribution
Distributed nationwide across the United States.
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