Safety Alerts & Recalls

What does this mean?

At this time, there have not been any reports of health problems associated with this recalled product. However, incorrectly sized tablets can lead to side effects by receiving too high of a dose or lack of effectiveness from receiving too low of a dose. Some side effects of too much PILOCARPINE include sweating, nausea, vomiting, changes in vision, headache, fast or slow heartbeat, tearing of eyes, difficulty breathing, and confusion. If you take recalled tablets that contain a lower dose than labeled you may not experience the symptom relief that you normally experience.

If you take PILOCARPINE 5 mg tablets, check your prescription bottle to see if your tablets were made by Sandoz and if your bottle has the product number NDC 0781-5100-01. The manufacturer and the product NDC number is often listed on the prescription label. If you think your tablets are made by Sandoz, or if you do not know who made your tablets, please return your bottle to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you may be experiencing side effects from PILOCARPINE, please contact your doctor as soon as possible.

Recall of a Single Lot of Pilocarpine Hydrochloride 5 mg Tablets

Corepharma, LLC has voluntarily recalled a single lot of PILOCARPINE 5 mg tablets made by Sandoz (product number NDC 0781-5100-01). PILOCARPINE is commonly used to treat dry mouth caused by radiotherapy in people with head and neck cancer and to treat dry mouth in people with Sjogren's syndrome. Lot number 100535 (Exp: Mar 2011) is being recalled because some tablets may be the wrong weight and thickness.

This recall alert only applies to this single lot of PILOCARPINE 5 mg tablets may by Sandoz. No other tablets and no pilocarpine eye products are involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-02-19
Last Updated: 2010-02-22

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