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L-citrulline by Medisca: UPDATE - Additional Lot Numbers Recalled
UPDATE 02/15/2014. FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline
- Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline. Pharmacists should see updated FDA Statement below for more product details.
- Medisca is voluntarily recalling all L-citrulline product with the above lot numbers.
- Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc.
- Patients and caregivers should stop using any product with these lot numbers.
- FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available.
Read the updated MedWatch safety alert at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385978.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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