Τετάρτη 13 Νοεμβρίου 2019

A MedWatch Safety Alert was added to the FDA Recalls webpage. 

Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Oral Solution), 15 mg/mL by Amneal Pharmaceuticals: Recall - Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Amneal Pharmaceuticals, has not received any reports of adverse events that have been confirmed to be directly related to this recall.For a complete list of recalled products, please read the recall announcement.
 
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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