Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

▤ Summary

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) 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 HCl 150mg and 300mg Capsules to the consumer level because of potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA. (Novitium’s press release: http://novitiumpharma.com/products/ranitidine-recall-press-release-final/External Link Disclaimer) To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The Ranitidine Hydrochloride Capsules being recalled are supplied as follows: GSMS, Inc. has promptly notified its consignees via email and certified mail. The lots under GSMS, Inc.’s voluntary recall have been primarily sold to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies (TMOP) as listed below: Consumers taking Ranitidine HCl capsules are advised to consult with their physician, pharmacist, or healthcare provider about an alternative treatment prior to discontinuing the use of the medication.

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$1M to $5M