Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96996

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 02, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tailstorm Health INC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 6

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, 85226, NDC 81483-0000-0.

D-0498-2025
Recall number
D-0498-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
29,700 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27

Distribution pattern

Nationwide in the US

drug · product 2 of 6

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. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.

D-0499-2025
Recall number
D-0499-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
975 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026

Distribution pattern

Nationwide in the US

drug · product 3 of 6

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.

D-0500-2025
Recall number
D-0500-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
23,200 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.

Distribution pattern

Nationwide in the US

drug · product 4 of 6

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.

D-0501-2025
Recall number
D-0501-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
14,725 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot: 2502009, Exp. 3/2/2026

Distribution pattern

Nationwide in the US

drug · product 5 of 6

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 85226, NDC 81483-0037-0.

D-0502-2025
Recall number
D-0502-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
2825 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026

Distribution pattern

Nationwide in the US

drug · product 6 of 6

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.

D-0503-2025
Recall number
D-0503-2025
Initiated
June 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Tailstorm Health INC
Quantity
4875 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 2504003, Exp. 04/03/2027

Distribution pattern

Nationwide in the US

Field note

Send feedback

We'll only use this to respond to your feedback.