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    • #48611
      TDP
      Keymaster

      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.M00813006/2022
      2.M00813106/2022
      3.M00813206/2022
      4.M00813306/2022
      5.M01008007/2022
      6.M01008107/2022
      7.M01102908/2022
      8.M01103008/2022
      9.M01103108/2022
      10.M01103208/2022
      11.M01130408/2022
      12.M01339409/2022
      13.M01339509/2022
      14.M01339609/2022
      15.M01396609/2022
      16.M01396709/2022
      17.M10083112/2022
      18.M10083212/2022
      19.M10083301/2023
      20.M10083401/2023
      21.M10126701/2023
      22.M10271801/2023
      23.M10271901/2023
      24.M10272001/2023
      25.M10272102/2023
      26.M10272202/2023
      27.M10417202/2023
      28.M10417302/2023
      29.M10417402/2023
      30.M10417502/2023
      31.M10417602/2023
      32.M10588903/2023
      33.M10589003/2023

      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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