Summary

Company announcement date:
FDA Release Date:
Type of product:
Medications
Reason for listing:

Reason for recall Description

N-nitrosodimethylamine (NDMA) Impurity

Company Name:
Viona Pharmaceuticals, Inc.
Brand:
Product Description:

Product Description

Metformin Hydrochloride Extended Release Tablets


Company announcement

FOR IMMEDIATE RELEASE – 12/28/2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., reminds voluntarily thirty-three (33) a lot of Metformin Hydrochloride Sustained Release Tablets, USP 750 mg to the level of detail. The reason for the recall is an out-of-specification result observed for said product, lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS / MS)” test at 17 months, 25 ° C / 60% RH Stability samples long-term. As a precaution, the company is voluntarily recalling all 33 lots marketed with a valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for distribution in the United States by Viona Pharmaceuticals Inc.

Risk statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. Patients who have received the affected lots of Metformin Hydrochloride Prolonged-Release Tablets, USP 750 mg are advised to continue to take their medicine and to contact their doctor for advice on alternative therapy. According to the FDA, it could be dangerous for patients with this serious illness to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma- metformin. To date, neither Viona Pharmaceuticals Inc. nor Cadila Healthcare Limited has received any adverse event reports related to this recall.

The product is used in addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. Firm recalled Metformin Hydrochloride Sustained Release Tablets, USP 750 mg are listed in the table below. The product can be identified as White to off-white, capsule shaped, uncoated tablets debossed with “Z”, “C” on one side and “20” on the other side. Metformin Hydrochloride Sustained Release Tablets, USP 750 mg has been distributed Nationwide to distributors.

Product Name: Metformin Hydrochloride Extended Release Tablets, USP 750 mg
NDC: 72578-036-01

Sr. No. Lot. Exp. Dated
1. M008130 06/2022
2. M008131 06/2022
3. M008132 06/2022
4. M008133 06/2022
5. M010080 07/2022
6. M010081 07/2022
seven. M011029 08/2022
8. M011030 08/2022
9. M011031 08/2022
ten. M011032 08/2022
11. M011304 08/2022
12. M013394 09/2022
13. M013395 09/2022
14. M013396 09/2022
15. M013966 09/2022
16. M013967 09/2022
17. M100831 12/2022
18. M100832 12/2022
19. M100833 01/2023
20. M100834 01/2023
21. M101267 01/2023
22. M102718 01/2023
23. M102719 01/2023
24. M102720 01/2023
25. M102721 02/2023
26. M102722 02/2023
27. M104172 02/2023
28. M104173 02/2023
29. M104174 02/2023
30. M104175 02/2023
31. M104176 02/2023
32. M105889 03/20/23
33. M105890 03/20/23

Viona Pharmaceuticals Inc., notify his clients through e-mail and courier (FedEx Overnight) and arrange for the return of all recalled products to our recall processor at the following address

Eversana Life Sciences Services
c / o Viona reminder
ATTN: Returns Department
4580 S. Mendenhall Road
Memphis, TN 38141

Consumers with questions regarding this recall can contact our recall processor. Eversana Life Science Services by phone at 1-888-304-5022, Option 1; Monday to Friday, 8:00 a.m. to 7:00 p.m. CDT. Consumers should contact their doctor or health care provider if they have had any problems that may be related to taking or using this medication.

Customers with medical questions, who wish to report an adverse event or quality concerns with the recalled products should contact Viona Pharmaceuticals Inc., by phone at: 888-304-5011Monday to Friday, 8:30 a.m. to 5:30 p.m. EST.

Adverse reactions or quality issues encountered while using this product can be reported to the MedWatch Adverse Event Reporting Program of the FDA, either online, by regular mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a report form, then complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178

This recall is being made with the knowledge of the United States Food and Drug Administration.


Company details

Consumers:
Eversana Life Sciences Services
1-888-304-5022

Product Pictures