The Recall Desk
ModerateFDA (Drugs)·D-0509-2016·Announced 2015-12-16

Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets Due to Impurities

Golden State Medical Supply Inc. is recalling 1,136 bottles of Meclizine Hydrochloride tablets because they failed impurity specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Golden State Medical Supply Inc. is recalling 1,136 bottles of Meclizine Hydrochloride Tablets, 12.5 mg, packaged in 1000-count bottles. The product is prescription-only and was distributed nationwide in the United States. The tablets were manufactured by Par Pharmaceuticals Companies Inc. and packaged by GSMS Incorporated.

The recall was initiated because the product failed impurities/degradation specifications, specifically being out of specification for impurities. The affected lots include GS007205, GS007344, GS008089, GS008842, GS009055, and GS009131, with expiration dates ranging from August 2017 to February 2018.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
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.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,136

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 (9)

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

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 →

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