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.
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drug · product 1 of 1
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
