The Recall Desk
SevereFDA (Drugs)·D-1578-2014·Announced 2014-09-10

Apotex Recalls PAXIL CR Tablets Due to Chemical Contamination

Apotex Inc. is recalling PAXIL CR 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (implied by chemical contamination of a prescription drug) are rated as Severe (4).

Plain-English summary

Apotex Inc. is recalling PAXIL CR (Paroxetine HCL) Controlled-Release Tablets, 25 mg, 30-count bottles. The product is prescription-only and was manufactured by GlaxoSmithKline in RTP, NC, for Apotex Corp. in Weston, FL.

The recall was initiated because the product was manufactured with active pharmaceutical ingredient (API) batches that were contaminated with residual materials and solvents. This is classified as a chemical contamination issue.

The affected product is identified by Lot # 2F004 and an expiration date of 06/15. The recall covers distribution nationwide and in Puerto Rico. Consumers should stop using the affected product and consult their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
PAXIL (PAROXETINE HYDROCHLORIDE)
Brand
PAXIL
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 (2)

  • Lot # 2F004
  • Exp. 06/15

UPCs (3)

  • 0360505366835
  • 0360505437733
  • 0360505366934

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 hazard · chemical contamination

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