FDA MedWatch - Ranitidine Capsules by Golden State Medical Supply: Recall

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Ranitidine Capsules by Golden State Medical Supply: Recall - Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) AUDIENCE: Patient, Consumer, Health Professional, Pharmacy ISSUE: Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of ranitidine hydrochloride capsules, 150 mg and 300 mg because of potential presence of NDMA above levels established by the FDA. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall. For a complete list of lot numbers, please click on the "Read Recall" button below. RECOMMENDATION: Patients/consumers taking ranitidine hydrochloride capsules are advised to consult with their physician, pharmacist, or healthcare provider about an alternative treatment prior to discontinuing the use of the medication.

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.

Read Recall