February 2021 FDA Recall Drug by Edge Pharma, Llc (D-0306-2021 - Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions)

This Class III drug recall was voluntarily initiated by Edge Pharma, Llc on February 17, 2021 for the product Drug. The FDA reported the reason for recall as temperature abuse; labeled with the incorrect room temperature (15-25 ¿c) storage conditions rather than the correct refrigerated (2 - 8 ¿c) storage conditions. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0306-2021

Reason for Recall
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Initiated
02-17-2021
Reported
03-24-2021
Quantity
213 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87348
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Edge Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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