The Recall Desk
SevereFDA (Drugs)·D-1575-2014·Announced 2014-09-10

Apotex Recalls PAXIL Oral Suspension Due to Chemical Contamination

Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was 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' rating under the rubric, particularly given the presence of chemical contamination in a prescription medication.

Plain-English summary

Apotex Inc. is recalling 13,429 bottles of PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL, 250 mL bottles. The product is distributed nationwide and in Puerto Rico. The affected lots are # 2A001 (Exp. 01/15) and # 2C002 (Exp. 03/15).

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 an FDA Class II recall.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
Manufacturer
Apotex Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
13,429

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 (4)

  • Lot # 2A001
  • Exp. 01/15
  • Lot # 2C002
  • Exp. 03/15

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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