DrugFeb 2, 2022
Edge Pharma Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution recall — FDA D-0405-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedEdge Pharma, LLC
Recall history in this database
Classification mix: Class II: 6, Class III: 1.
DrugFeb 2, 2022
Edge Pharma Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 recall — FDA D-0424-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedEdge Pharma, LLC
DrugFeb 2, 2022
Edge Pharma Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single recall — FDA D-0425-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedEdge Pharma, LLC
DrugApr 28, 2021
Edge Pharma Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe recall — FDA D-0335-2021
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class IIFDA: TerminatedEdge Pharma, LLC
DrugMar 24, 2021
Edge Pharma Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution recall — FDA 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
Class IIIFDA: TerminatedEdge Pharma, LLC
DrugJan 27, 2021
Edge Pharma Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg recall — FDA D-0238-2021
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class IIFDA: TerminatedEdge Pharma, LLC
DrugJan 20, 2021
Edge Pharma Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml recall — FDA D-0226-2021
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class IIFDA: TerminatedEdge Pharma, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Edge Pharma, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.