Drug 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

D-0306-2021

February 17, 2021

Class III

Product summary

Firm: Edge Pharma, LLC
Event: Event 87348
Status: Terminated
Classification: Class III
Quantity: 213 kits
Official record key: drug-enforcement:D-0306-2021

Official wording

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

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

Distribution pattern: Nationwide in the US

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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