Viona Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg Due to the Detection of NDMA Impurity

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      TDP
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      December 28, 2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recall all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.

      Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition 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 have received any reports of adverse events related to this recall.

      The product is used as an adjunct to diet and exercise to improve blood glucose 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 Extended-Release Tablets, USP 750 mg are listed in the below table. 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 Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.

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

      Sr. No. Batch No. Exp. Date
      1. M008130 06/2022
      2. M008131 06/2022
      3. M008132 06/2022
      4. M008133 06/2022
      5. M010080 07/2022
      6. M010081 07/2022
      7. M011029 08/2022
      8. M011030 08/2022
      9. M011031 08/2022
      10. 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 03/2023
      33. M105890 03/2023

      Viona Pharmaceuticals Inc., is notifying its customers by email and mail (FedEx Overnight) and is arranging for return of all recalled products to our recall processor at the following address

      Eversana Life Science Services
      c/o Viona recall
      ATTN: Returns Department
      4580 S. Mendenhall Rd.
      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 – Friday, 8:00 am – 7:00 pm CDT. 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.

      Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Viona Pharmaceuticals Inc., by phone at: 888-304-5011, Monday – Friday, 8:30 am – 5:30 pm, EST.

      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

      This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

      Source: FDA

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