FDA MedWatch - Ranitidine Syrup, 15 mg/mL (Ranitidine Oral Solution USP) by Lannett: Recall

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Ranitidine Syrup, 15 mg/mL (Ranitidine Oral Solution USP) by Lannett: Recall - Due to Levels of N-Nitrosodimethylamine (NDMA) above the Levels Recently Established by the FDA AUDIENCE: Patient, Consumer, Health Professional, Pharmacy ISSUE: Lannett Company is voluntarily recalling all lots within expiry of Ranitidine Syrup, 15mg/mL (Ranitidine Oral Solution USP) due to levels of NDMA above the levels recently established by the FDA for Ranitidine Hydrochloride Syrup (Ranitidine Oral Solution, USP). NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product. The analysis confirmed the presence of NDMA. Please click the "Read Recall" button below to view the list of affected lots. RECOMMENDATION: Patients and consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Patients, consumers and health care professionals 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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