Reported Sep 10, 2014 · Terminated

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC…

Apotex Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Apotex Inc. · 150 Signet Drive · Toronto · N/A

Is this the product you have?

  • Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1Lot # 2A002, Exp. 01/15
2Lot # 2A003, Exp. 01/15
3Lot # 2C004, Exp. 03/15
4Lot # 2C005, Exp. 03/15
5Lot # 2E008, Exp. 05/15
6Lot # 2F009, Exp. 06/15
7Lot # 2F010, Exp. 06/15
8Lot # 2H011, Exp. 08/15
9Lot # 2H012, Exp. 08/15
10Lot # 2H013, Exp. 0815

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 23, 2014 · Data as of Sep 19, 6:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.