FDAClass IIIMarch 24, 2021

Methacholine Challenge 5-Syringe Test Kits recall

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr.…

Why was Methacholine Challenge 5-Syringe Test Kits recalled?

Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 12-2020-16@10, BUD 3-30-21 Lot # 11-2020-18@11, BUD 3-02-21

Product
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr.…
Recalling firm
Edge Pharma, LLC
Quantity
213 kits
Distribution
Nationwide in the US
Recall date
March 24, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls