The FDA this week announced two drug recalls for entirely different but nonetheless equally serious reasons. The first recall involves Metformin Hydrochloride Extended-Release tablets from Viona Pharmaceuticals. This recall stems from the fact that some lots of the drug likely contain a carcinogen known as N-nitrosodimethylamine (NDMA). The second drug recall involves lots of Nitroglycerin Lingual Spray and is due to the fact that some units may not properly dispense the medication as intended.
The Metformin Hydrochloride drug recall
Metformin Hydrochloride is for patients with type 2 diabetes. Again, this recall was issued because 33 batches of the drug were found to have a carcinogen known as NDMA. It’s worth noting that the FDA, in contrast to other recalls we’ve seen, still urges patients who have the medication in their possession to continue taking it until they can get a different batch or an alternate treatment. The reason is that patients with serious medical conditions can experience serious side effects if they abruptly stop taking their medication. Naturally, anyone who finds themselves in this predicament should contact their primary care physician immediately for guidance.
“The product can be identified,” the FDA notes, “as white to off-white, capsule-shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side.” The drug is available in 750 mg tablets and was available to patients across the country.
With respect to NDMA, we previously explained:
NDMA — short for N-Nitrosodimethylamine — is a naturally-occurring compound that can be found in a variety of foods as well as water sources. It’s thought to be a human carcinogen, meaning that it promotes the growth of cancer in humans, and as such there are regulations to limit the amount of NDMA in all medications.
The expiration date on tablets subject to the drug recall range from June 2022 through March 2023.
Consumers with questions about this recall can contact Viona Pharmaceuticals at 1-888-304-5011. The hotline is open from Monday through Friday. The hours of operation are from 8:30 AM through 5:30 PM Eastern Time.
The Nitroglycerin Lingual Spray dispenser
This drug recall was announced by Padagis US earlier this week. As mentioned above, some Nitroglycerin Lingual Spray units do not dispense the medication as designed. Consequently, there is a chance, however small, that individuals who need the medication will not receive it. The medication is for individuals who need immediate relief due to an attack or pain stemming from coronary artery disease.
Note that this drug recall exclusively applies to the 12g spray bottle unit. The 4.9g spray bottle isn’t subject to recall. All told, the three lots subject to the recall are 150892, 153199, 156041. The respective expiration dates for these lots are October 2022, February 2023, and April 2023. The branding on the product lists Perrigo Company PLC.
Any individuals who use the drug should check to see if they have the 12g spray unit. If so, the FDA advises to throw it away immediately. Similarly, healthcare providers with the 12g spray unit should stop distributing it to patients.
Consumers with questions about the recall can call a support line at 1-888-266-7912. The hotline is open Monday through Friday. Its hours of operation are from 8 AM through 5 PM Eastern Time.