JAN. 13 UPDATE: Viona re-announced this December recall on Friday, but to the consumer level instead of just the retail level. The 23 lots recalled are included in the 33 below. Viona says 10 lots never were released commercially. Inmar Pharmaceutical Services is answering customer questions about the recall at 855-249-3303, Monday through Friday, 9 a.m. to 5 p.m. and Inmar is taking in the returned recalled medication at 3845 Grand Lakes Way, Grand Prairie, Texas, 75050.
Viona Pharmaceuticals has recalled all 33 lots of type 2 diabetes drug 750 mg strength metformin with remaining shelf life after long-term testing on one of the lots revealed too much NDMA.
NDMA, or N-nitrosodimethylamine, is classified as a probable human carcinogen and was the reason for numerous metformin recalls in 2020.
What metformin is recalled?
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg in 100-count bottles. Viona’s FDA-posted recall describes the tablets as “white to off-white, capsule-shaped, uncoated...debossed with “Z”, “C” on one side and “20” on the other side.”
Recalled are batch Nos. M008130-133, exp. date 06/2022; M010080-81, exp. 07/2022; M011029-32, exp. 08/2022; M013394-96, M013966-67, exp. 09/2022; M100831-32, exp. 12/2022; M100833-34, M101267, M102718-20, exp. 01/2023; M102721-22, M104172-76, exp. 02/2023; M105889-90, exp. 03/2023.
What should you do now?
This isn’t a case of a pill being able to give you cancer instantly, but rather that your chances of getting cancer rise with long-term use of the drug. So, as was the case with previous metformin recalls, the manufacturer advises to keep taking the metformin until your doctor or pharmacist shifts you to another treatment.
Viona says it’s arranging for customers to return the unused metformin to Eversana Life Science Services, c/o Viona recall, ATTN: Returns Department, 4580 S. Mendenhall Rd., Memphis, TN 38141.
If you have questions about the recall, contact Eversana at 888-304-5022, option No. 1, Monday through Friday, 9 a.m. to 8 p.m., Eastern time.
If this or any other drug causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
Only then do you call the manufacturer or distributor, in this case, Viona, at 888-304-5011, Monday through Friday, 8:30 a.m. to 5:30 p.m., Eastern time.
This story was originally published December 29, 2021 9:18 AM.