redacted — FDA recall recorded on 2026-06-10, published by openFDA (U.S. Food and Drug Administration). openFDA names redacted as manufacturer on this product's label.
redacted — FDA recall recorded on 2026-06-10, published by openFDA (U.S. Food and Drug Administration). openFDA names redacted as manufacturer on this product's label. EV-01
Manufacturer read from openFDA manufacturer field + product label legend, read on 1 record at redacted · confidence: medium · The publisher names a firm other than the applicant on this product's label. The label states a manufacturing or packaging role; it does not state the commercial terms, the sites involved, or whether the relationship is current.
| This work needs | Your profile says | |
|---|---|---|
| this dosage form | Sterile Injectable · capabilities.dosageForms | ✓ match |
| you also operate in this country | United States · facilities.geography | · context, not scored |
| this work is already made by a named third party | ████████████ · record.product.description | ✓ opportunity, scored |
| this modality | Biologics Drug Product, Biologics Manufacturing · capabilities.modality | ✓ match |
| therapeutic area | no overlap found on this dimension · capabilities.therapeuticAreas | not matched |
Every dossier is joined on the same 5 dimensions. Only the 2 capability dimensions — modality, dosage form — are counted, and they are the denominator in match 2/2. geography and therapeutic area are context: true of both sides, worth stating, and not evidence that you can make the product — so they are shown and not scored. named incumbent manufacturer is an opportunity dimension: it says nothing about what you can make, it says the work is already being done by somebody else and is therefore winnable. It is scored and it is deliberately outside the capability fraction — a card still needs a real capability match to exist at all. not matched means we evaluated the dimension and found no overlap; it does not say which side was silent.
These two dimensions are one fact. The INN stem classifies this molecule as "Monoclonal Antibody (mAb)", and that class is parenteral by construction — so "Sterile Injectable" was already knowable from the molecule class and is not a second, independent test of fit. Read this as one match on two axes, not as two pieces of corroboration.
Matches redacted on incumbent redacted; dosage form Sterile Injectable; modality Biologics Drug Product, Biologics Manufacturing; you have a site in United States. The affected product is a vial.
- EV-01redacted · classification: Class II · reason for recall: Lack of assurance of Sterility: · product quantity: 326 vials · status: Ongoing · voluntary or mandated: Voluntary: Firm initiatedsupportingopenFDA (U.S. Food and Drug Administration) · retrieved Aug 27, 2026
product ████, (████) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by ████████████, ████████████, Manufactured at: ████████████, ████████████, NDC ████.
We reviewed 1 record and found nothing that weakens this lead. Checked, none found — not skipped.
caveatThe publisher names a firm other than the applicant on this product's label. The label states a manufacturing or packaging role; it does not state the commercial terms, the sites involved, or whether the relationship is current.
| Source | Status | Last checked |
|---|---|---|
| FDA Import Alerts | checked_no_match | Aug 27 · 03:00 |
| FDA Inspection Classifications (NAI/VAI/OAI) | source_unavailableLive cadence unavailable: FDA Data Dashboard requires an Authorization-Key (free, but obtained by a human via FDA OII Unified Logon; not yet configured). Serving the on-disk export retrieved 2026-02-27. | Aug 27 · 03:00 |
| FDA Warning Letters | source_unavailableLive cadence unavailable: FDA's static warning-letter JSON is an archive whose most recent letter is 2021-11-10 (1751 days old). Current letters exist only on FDA's JavaScript-rendered listing, which serves no rows server-side. Serving the archive; do not read these as current signals. | Aug 27 · 03:00 |
| openFDA Drug Enforcement (Recalls) | matchedassessed 410 of 430 · 20 withheld — source record omits product form5 published · 17 withheld — 11 below the edition quality floor — 4 urgency window elapsed — 2 below confidence threshold 0.25 | Aug 27 · 03:00 |
| Trade-press facility signals | checked_no_match | Aug 27 · 03:00 |
| WARN Notices (state layoff filings) | checked_no_match | Aug 27 · 03:00 |
| ClinicalTrials.gov late-stage transitions | not_checkedPartial read this run — we could not see the whole window, so we cannot report that there was nothing here for you. TRUNCATED: fetched 500 of 6341 matching records (7.9%) — this run saw a sample, not the window — stopped at our own row ceiling | — |
| SEC EDGAR financing & manufacturing filings | checked_no_match | Aug 27 · 03:00 |
| FDA approvals & priority review | matchedPartial read this run — we could not see the whole window, so we cannot report that there was nothing here for you. TRUNCATED: fetched 500 of 3297 matching records (15.2%) — this run saw a sample, not the window — stopped at our own row ceiling2 published · 65 withheld — 61 below the edition quality floor — 3 urgency window elapsed — 1 edition full — ranked below the cut | Aug 27 · 03:00 |
| Federal Register — FTZ production activity & pharma trade actions | checked_no_match | Aug 27 · 03:00 |
| FDA Orange Book — patent & exclusivity expiry | matched_all_withheld0 published · 77 withheld — 75 trigger date has not occurred yet — 2 below the edition quality floor | Aug 27 · 03:00 |
| Top-pharma IR & newsroom facility signals (direct fetch) | checked_no_match | Aug 27 · 03:00 |
| FDA Purple Book — biologics exclusivity | source_unavailableFDA publishes no stable machine-readable Purple Book URL; the download link on purplebooksearch.fda.gov/downloads is dated and rotates monthly. Reporting unavailable rather than emitting a false "no biologics LOE found". | Aug 16 · 14:52 |
| Top-pharma newsrooms via browser crawl | checked_no_match | Aug 15 · 22:06 |
| Find Events — congress & publication activity | not_checkedNo source adapter is configured for this feed yet, so it was not queried this run. | — |
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