Amneal Recalls Ranitidine Products Due to Potential NDMA Impurity

Amneal Pharmaceuticals has issued a voluntary recall of its ranitidine tablets, 150 mg and 300 mg, as well as ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL, to the consumer level, according to a company announcement.

The recall is due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Used in both OTC and prescription drugs, ranitidine is a histamine-2 blocker that decreases the amount of acid produced in the stomach. NDMA is classified as a probable human carcinogen, and is a known contaminant found in water and foods.

As part of an ongoing investigation of NDMA levels in ranitidine, the FDA has tested numerous ranitidine products over the past few months. FDA testing found that levels reported in some of these medications are much lower than previously reported by a few third-party investigators, but levels still exceeded what the agency considers acceptable.

As a result, the FDA has recommended recalls to manufacturers with products containing NDMA levels above the acceptable daily intake limit. The agency is also asking manufacturers to continue conducting their own laboratory testing to examine these levels of NDMA in ranitidine and nizatidine products as well as to send samples to the FDA to be tested by their scientists.

The FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine.

The recalled lots include ranitidine tablets, USP:

• 150 mg, 60 count, NDC number: 65162-253-06
• 150 mg, 100 count, NDC number: 65162-253-10
• 150 mg, 180 count, NDC number: 65162-253-18
• 150 mg, 500 count, NDC number: 65162-253-50
• 150 mg, 1000 count, NDC number: 65162-253-11
• 150 mg, 1000 count, NDC number: 53746-253-10
• 300 mg, 30 count, NDC number: 65162-254-03
• 300 mg, 100 count, NDC number: 65162-254-10
• 300 mg, 250 count, NDC number: 65162-254-25
• 300 mg, 250 count, NDC number: 53746-254-02

Ranitidine syrup (ranitidine oral solution, USP) 15 mg/mL; 6 fluid ounces, 473 mL (NDC number: 65162-664-90) has also been recalled.

Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

REFERENCE

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity [company announcement]. FDA’s website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg. Accessed November 25, 2019.