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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72733

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 25, 2015
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Golden State Medical Supply Inc.

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

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, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.

D-0509-2016
Recall number
D-0509-2016
Initiated
November 25, 2015
Classification
Class III
Status
Terminated
Quantity
1136 Bottles

App-derived interpretation

Potency or specification failure reason.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

Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.

Distribution pattern

U.S. Nationwide

drug · product 2 of 2

MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

D-0510-2016
Recall number
D-0510-2016
Initiated
November 25, 2015
Classification
Class III
Status
Terminated
Quantity
a) 737 Bottles; b) 3863 Bottles

App-derived interpretation

Potency or specification failure reason.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 #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.

Distribution pattern

U.S. Nationwide