The Recall Desk
SevereFDA (Drugs)·D-1581-2014·Announced 2014-09-10

Apotex Recalls PAXIL Tablets Due to Chemical Contamination

Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients 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' rating under the rubric, particularly given the nature of chemical contamination in a prescription medication.

Plain-English summary

Apotex Inc. is recalling PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottles, NDC 60505-3664-3. The affected product is identified by Lot # 2ZP5499 and an expiration date of 02/15. The product 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 was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.

The recalled product

Product
PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3
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 # 2ZP5499
  • Exp. 02/15

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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