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.
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
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
