Safety Alerts & Recalls

What does this mean?

Upsher-Smith has determined that the risk of serious injury in someone taking any of the recalled products is low and has only recalled these medicines at the warehouse and pharmacy level only. That said, if you take Amandatine 100 mg, Amlodipine 5 mg, Androxy 10 mg, Baclofen 10 mg, Bethanechol 5 mg, 10 mg, and 25 mg, or Oxybutynin 5 mg, please check your prescription and follow up with your pharmacist if your tablets do not look the same as what you usually receive. If you have concerns about this recall or think you are experiencing side effects, please follow up with your doctor, pharmacist, or other healthcare professional.

Consumers and pharmacists can call the Upsher-Smith at 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST). Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the recalled medicine to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin

Upsher-Smith Laboratories, Inc. is voluntarily expanding its previously announced recall of Jantoven Warfarin Sodium, USP, 3 mg Tablets to include products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating this expanded recall as a precautionary measure because a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed.

The following products were added to the recall: Amandatine 100 mg

Amlodipine 5 mg

Androxy 10 mg

Baclofen 10 mg

Bethanechol 5 mg, 10 mg, and 25 mg

Oxybutynin 5 mg

The accidental substitution of a different medicine may lead to a change in the effectiveness or possible side effects from the medicines involved.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-02-24
Last Updated: 2011-02-24

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