The Recall Desk

FDA (Drugs) recall action 89172

Edge Pharma, LLC recalled 56 products on 2022-02-02

The FDA (Drugs) publishes a recall like this one as 56 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 56 pages.

Products
56
Announced
2022-02-02
Critical
0
Units
113,123

Why these products were recalled

Lack of Assurance of Sterility

CGMP Deviations

Lack of Assurance of Sterility.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–56 of 56

  • ModerateFDA (Drugs)··2022-02-02

    Drug Recall: Cantharidin Gel-Forming Suspension CGMP Deviations

    Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.

    Product
    Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2022-02-02

    Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.

    Product
    Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations

    Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.

    Product
    Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    Tetracaine HCl Nasal Solution Recalled for Manufacturing Deviations

    Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.

    Product
    Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-02-02

    Phenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance

    Edge Pharma is recalling approximately 5,335 syringes of Phenylephrine HCl Sterile Solution for Injection nationwide due to lack of assurance of sterility. The product may not meet sterility requirements for safe use.

    Product
    Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
    Category
    Distribution
    0 states