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 2
Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug
Code information
Lot #: 310935 Exp 3/31/2015; Lot #: 3109552 Exp 3/31/2015; Lot #: 3110204, Exp 3/31/2015; Lot #: 3112972, Exp 7/31/2015; Lot #: 3114073, Exp 8/31/2015; Lot #: 3115756, Exp 10/31/2015, Lot #: 3115888, Exp 10/31/2015; Lot #: 3118059, Exp 11/30/2015.
Distribution pattern
Nationwide
drug · product 2 of 2
Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug
Code information
Lot #: 3109554, Exp 3/31/2015; Lot #: 3111457, Exp 3/31/2015; Lot #: 3112973, Exp 7/31/2015; Lot #: 3114262, Exp 6/30/2015; Lot #: 3114076, Exp 12/31/2015; Lot #: 3115889, Exp 12/31/2015; Lot #: 3116033, Exp 12/31/2015.
