The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1576-2014·Announced 2014-09-10

Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves chemical contamination (residual materials and solvents) in a prescription drug, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg, 30-count bottles. The product is a prescription-only medication manufactured by GlaxoSmithKline in RTP, NC, and manufactured for Apotex Corp. in Weston, FL. The recall involves NDC 60505-3674-3 and specific lot numbers with expiration dates ranging from January 2015 to August 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 poses a potential risk to patients taking 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 the recall notice. If the medication matches the recalled lots, patients should stop using it and contact 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 (11)

  • Lot # 2A002
  • Exp. 01/15 Lot # 2A003
  • Exp. 01/15 Lot # 2C004
  • Exp. 03/15 Lot # 2C005
  • Exp. 03/15 Lot # 2E008
  • Exp. 05/15 Lot # 2F009
  • Exp. 06/15 Lot # 2F010
  • Exp. 06/15 Lot # 2H011
  • Exp. 08/15 Lot # 2H012
  • Exp. 08/15 Lot # 2H013
  • Exp. 0815

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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