Heartburn Medication Recall 2019: Another Round Of Recalls For Ranitidine For Cancer-Causing Impurity

After several recalls for the heartburn medication ranitidine, Golden State Medical Supply Inc. has issued its own recall for 19 lots of ranitidine because it may contain a cancer-causing impurity.

The recall was initially issued by the manufacturer of the medication, Novitium Pharma LLC, because the medication may contain Nitrosodimethylamine (NDMA) – a cancer-causing impurity – above the levels set by the U.S. Food & Drug Administration (FDA).

The ranitidine capsules are used for the treatment of duodenal ulcers, benign gastric ulcers, reflux esophagitis, post-operative peptic ulcers, Zollinger-Ellison Syndrome, and other medical conditions gastric and acid secretion disorders.

The recall affects seven lot of 150 mg ranitidine HCl and 12 lots of 300 mg ranitidine HCl capsules. The affected heartburn medication was sold primarily to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies.

The recall includes:

• 150 mg ranitidine capsules that are caramel-colored and have 001 imprinted on the cap and novitium 150 mg on the body in white ink. The capsules are filled with a white to pale yellow powder.
• 300 mg ranitidine capsules that are caramel-colored and have 002 imprinted on the cap and novitium 300 mg on the body in white ink. The capsules are filled with a white to pale yellow powder.

A full list of lot numbers, NDC numbers, and expiration dates can be viewed here.

Consumers that are taking the recalled ranitidine capsules should consult their healthcare provider or pharmacist for an alternative treatment plan prior to discontinuing the use of the medication.

To return the medication, consumers should contact Novitium’s recall processor to obtain instructions and kit only after an alternative treatment plan has been prescribed. Consumers should call 1-866-382-8606 or email Novitiumpharma6639@stericycle.com.

Questions about the recall can be directed to Golden State Medical Supply by phone at 1-800-284-8633, Ext. 215, Monday through Friday from 7:30 a.m. to 4 p.m. PST, by fax at 1-805-437-7588, or by email at recalls@gsms.us.

The company said it has not received any reports of adverse reactions due to the recalled medication.