Home / Recalls / Edge Pharma, LLC / D-0306-2021

D-0306-2021 Class III Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

FDA drug recall D-0306-2021 was initiated by Edge Pharma, LLC on February 17, 2021 and is designated Class III. 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 The recall status is terminated (terminated June 10, 2021). Affected quantity: 213 kits.

Recall Details

Product Type
Drugs
Report Date
March 24, 2021
Initiation Date
February 17, 2021
Termination Date
June 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
213 kits

Product Description

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

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

Distribution Pattern

Nationwide in the US

Code Information

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

Other recalls by Edge Pharma, LLC

  • D-0399-2022 Class II — Dexamethasone sodium phosphate, sterile otic solution for injection Preservative (December 6, 2021)
  • D-0402-2022 Class II — Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservativ (December 6, 2021)
  • D-0446-2022 Class II — Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single D (December 6, 2021)
  • D-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)
  • D-0444-2022 Class II — Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip (December 6, 2021)
  • D-0434-2022 Class II — Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v (December 6, 2021)
  • D-0436-2022 Class II — LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont (December 6, 2021)
  • D-0420-2022 Class II — Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d (December 6, 2021)
  • D-0403-2022 Class II — Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL (December 6, 2021)
  • D-0419-2022 Class II — Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva (December 6, 2021)

FDA data resources