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.
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drug · product 1 of 1
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
Potency or specification failurereason.potency_specification_failure · v1.0.0
SubPotent
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Code information
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
