The Recall Desk

FDA (Drugs) recall action 96996

Tailstorm Health INC recalled 6 products on 2025-07-09

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2025-07-09
Critical
0
Units
76,300

Why these products were recalled

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

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.

1–6 of 6

  • SevereFDA (Drugs)··2025-07-09

    Bupivacaine HCL Sterile Injection Recalled for Sterility Assurance Concerns

    Tailstorm Health Inc. is recalling bupivacaine HCL sterile injection vials nationwide due to FDA inspection findings regarding concerns with the sterile manufacturing process.

    Product
    BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-07-09

    Compounded lidocaine with epinephrine vials lack assurance of sterility

    Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.

    Product
    LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2025-07-09

    Lidocaine HCL Sterile Injection recalled for sterility assurance concerns

    Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection (20 mg/mL) due to FDA inspection findings of concerns with the sterile manufacturing process. The recalled product is distributed nationwide.

    Product
    LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-07-09

    Compounded ketamine injection recalled over lack of sterility assurance concerns

    Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-07-09

    Compounded ketamine multi-dose vials recalled over sterility assurance concerns

    Ketamine Hydrochloride Injection 500 mg/5 mL multi-dose vials compounded by Medivant Healthcare are being recalled for lack of assurance of sterility. 14,725 vials are affected.

    Product
    KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-07-09

    Compounded preservative-free lidocaine vials lack assurance of sterility

    Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.

    Product
    LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
    Category
    Distribution
    0 states