The Recall Desk
LowFDA (Drugs)·D-0510-2016·Announced 2015-12-16

Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets for Impurities

Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride Tablets, 25 mg, packaged in 100-count and 1,000-count bottles. The recall involves specific lots of the medication, which is a prescription-only drug manufactured by Par Pharmaceuticals Companies Inc. and packaged by GSMS Incorporated.

The recall was initiated because the tablets failed impurities/degradation specifications, specifically being out of specification for impurities. The affected products were distributed nationwide in the United States.

Consumers who have these specific lots of Meclizine Hydrochloride Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on returning the product or obtaining a replacement.

The recalled product

Product
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.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Lot #: GS005908
  • Expiry: Jun-17
  • Lot #: GS006088
  • Lot #: GS006254
  • Expiry: Sep-17
  • Lot #: GS007345
  • Lot #: GS007664
  • Lot #: GS007803

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Golden State Medical Supply Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Golden State Medical Supply Inc.

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Same hazard · impurities

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