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
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
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 Impurities/Degradation Specifications: Out of specification for impurities.
Code information
a) Lot #: 24820001, Expiry: NOV 2015; Lot #: 25783601, Expiry: OCT 2016; Lot #: 25783801, Expiry: OCT 2016; Lot #: 26731201, Expiry: AUG 2017; Lot #: 26762002, Expiry: FEB 2018. b) Lot #: 26683201, Expiry: AUG 2017; Lot#: 26762001, Expiry: FEB 2018.
Distribution pattern
U.S. Nationwide including Puerto Rico
drug · product 2 of 2
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
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 Impurities/Degradation Specifications: Out of specification for impurities.
Code information
a) Lot #: 25552101, Expiry: AUG 2016; Lot#: 25712701, Expiry: SEP 2016; Lot #: 25787902, Expiry: NOV 2016; Lot #: 26074601, Expiry: JAN 2017; Lot #: 26259801, Expiry: APR 2017; Lot #: 26220001, Expiry: MAR 2017; Lot #: 26579001, Expiry: JUN 2017; Lot #: 26731801, Expiry: NOV 2017. b) Lot #: 24502301, Expiry: OCT 2015; Lot #: 24505901, Expiry: OCT 2015; Lot #: 25787901, Expiry: NOV 2016; Lot #: 26074701, Expiry: JAN 2017; Lot #: 26259701, Expiry: MAR 2017; Lot #: 26575801, Expiry: JUN 2017; Lot #: 26579002, Expiry: JUN 2017; Lot #: 26682801, Expiry: SEP 2017; Lot #: 26682901, Expiry: SEP 2017; Lot #: 26731702, Expiry: NOV 2017; Lot #: 25960301, Expiry: NOV 2017; Lot #: 26764801, Expiry: MAR 2018.
