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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72970

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
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

Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.

D-0657-2016
Recall number
D-0657-2016
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Safecor Health, LLC
Quantity
132 unit dose cups

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

Code information

Lot: 932333, Exp 08/04/16

Distribution pattern

NY