The Recall Desk
SevereFDA (Drugs)·D-1574-2014·Announced 2014-09-10

Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, as it involves a chemical contamination that could cause serious health consequences.

Plain-English summary

Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets, 12.5 mg, 30-count bottles. The product is a prescription medication manufactured by GlaxoSmithKline for Apotex Corp. The recall covers lots 2A001, 2A002, 2C003, 2F005, and 2G006, which have expiration dates ranging from January 2015 to July 2015.

The recall was initiated because the product was manufactured with active pharmaceutical ingredient (API) batches that were contaminated with residual materials and solvents. This chemical contamination represents a potential safety risk to patients using the medication.

The affected products were distributed nationwide and in Puerto Rico. Patients and healthcare providers should check their medication bottles for the specific lot numbers and expiration dates listed in this notice. If the medication matches the recalled lots, patients should stop using it and consult their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Brand
PAROXETINE HYDROCHLORIDE
Manufacturer
Apotex 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 (6)

  • Lot # 2A001
  • Exp. 01/15 Lot # 2A002
  • Exp. 01/15 Lot # 2C003
  • Exp. 03/15 Lot # 2F005
  • Exp. 06/15 Lot # 2G006
  • Exp. 07/15

UPCs (3)

  • 0360505367436
  • 0360505367535
  • 0360505367337

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Apotex 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 9 products in this recall →

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Same brand · PAROXETINE HYDROCHLORIDE

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Same hazard · chemical contamination

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