The Recall Desk
HighFDA (Drugs)·D-0405-2022·Announced 2022-02-02

Methacholine Challenge Test Kit Recalled for Lack of Sterility Assurance

Edge Pharma, LLC is recalling Methacholine Challenge 5-Syringe Test Kits nationwide due to lack of assurance of sterility. The sterile inhalation solution may not meet sterility standards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile inhalation product with lack of sterility assurance. Although no reported illnesses or injuries are stated in the source text, sterile injectable/inhalation products with sterility defects pose a risk of serious harm due to potential infection if administered to patients. Per the rubric, products with risk-of-harm where injury has not yet been reported score 3 (High).

Plain-English summary

Edge Pharma, LLC is recalling Methacholine Challenge 5-Syringe Test Kits (NDC 05446-1600-05) and associated individual syringes containing Methacholine Chloride at various concentrations (16 mg/mL, 4 mg/mL, 1 mg/mL, 0.25 mg/mL, and 0.0625 mg/mL). The product is a sterile inhalation solution, preservative-free, with 3 mL per syringe. The recall affects approximately 1007 syringes distributed nationwide.

The recall has been initiated due to lack of assurance of sterility for this inhalation product. The manufacturer is Edge Pharma, LLC, located at 856 Hercules Dr., Colchester, VT 05446. Affected lot codes are 09-2021-03@6 (dated 12/16/2021) and 10-2021-06@7 (dated 01/18/2022).

Consumers and healthcare providers who have received this product should stop using it immediately and contact their healthcare provider or Edge Pharma, LLC for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg),
Manufacturer
Edge Pharma, LLC
Category
Drug — Diagnostic / Challenge Test Kit
Hazard
  • sterility-assurance
  • inhalation-product

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 (1)

  • 09-2021-03@6 12/16/2021 & 10-2021-06@7 01/18/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category