Safety Alerts & Recalls

What does this mean?

This recall for Leflunomide tablets, 10 mg and 20 mg from Apotex was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you take Leflunomide tablets, 10 mg and 20 mg and are concerned, you should speak to your doctor.

Apotex Recalls Several Lots of Leflunomide tablets,10 mg and 20 mg

Apotex has recalled several lots of Leflunomide tablets, 10 mg and 20 mg. The following lot numbers have been recalled because routine testing found that the amount of active ingredient was too low in several samples from these lots: Leflunomide tablets, 10 mg: Lot numbers GY4197 and GZ1273

Leflunomide tablets, 20 mg: Lot number GZ1274

Leflunomide is used in the treatment of rheumatoid arthritis. This recall alert only applies to the select lots of the generic Leflunomide tablets, 10 mg and 20 mg made by Apotex. No other Leflunomide products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2012-09-17
Last Updated: 2012-09-17

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