Ranitidine Tablets Recall: Pills tainted with probable cancer-causing agent
The Apotex Corp. is recalling Ranitidine Tablets 75mg and 150mg, all pack sizes and formats.
On September 25, the U.S. Food and Drug Administration alerted health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen – i.e. a substance that could cause cancer.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said Acting FDA Commissioner Ned Sharpless, M.D.
“We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”
Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Earlier this week, the agency provided the following information for patients and health care professionals on the recall of ranitidine capsules produced by Sandoz:
- If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the company. This information is available on the FDA’s website and also indicated toward the end of this article.
- While the FDA investigates the root cause and risk, consumers and patients can continue to take ranitidine that has not been recalled. It is important to remember that not all ranitidine marketed in the U.S. is being recalled.
- Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
- Consumers taking OTC ranitidine could consider using other OTC products for their condition.
“We are continuing our investigation along with our international counterparts, and we will keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The agency is testing ranitidine products from multiple manufacturers and assessing the possible effect on patients who have been taking ranitidine, as well as what manufacturers can do to reduce or eliminate nitrosamine in drugs.
Recall instructions:
Wholesalers, Distributors and Retailers should return the impacted product to place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 800-967-5952 (option 1) (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.
Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For more on the recall, see the video accompanying this article.
(Source: FDA)
~ Posted by Richard Webster, Ace News Today / Connect with Richard on Facebook and Twitter
