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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97977

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 10, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Safecor Health, LLC

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

1 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 1

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.

D-0214-2026
Recall number
D-0214-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
800 1mL vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Not Elsewhere Classified:Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Code information

Lot 25381993 and 25391516, Exp 12/31/2026

Distribution pattern

Distributed in Massachusetts