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
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
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 stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Code information
Lot #: a) D06017, D06018, Exp 9/18; D06028 Exp 10/18; b) D06014, D06015, D06016, Exp 9/18; D06024, D06025, D06026, D06027, Exp 10/2018; c) D06011, D06012, D06013, Exp 9/18; D06020, D06021, D06022, D06023, Exp 10/2018
