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
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Code information
Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
