Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

N-Nitrosodimethylamine (NDMA) Impurity

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

Product Description

Metformin Hydrochloride Extended-Release Tablets


Company Announcement

FOR IMMEDIATE RELEASE – 01/07/2022 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling twenty-three (23) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The reason for the recall is an Out of Specification (OOS) result observed for one lot of the product (M008132) “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which we have determined having a valid shelf life within the US market. 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. The recalled lots of 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

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

Inmar Pharmaceuticals Services-Recalls 3845 Grand Lakes Way, Grand Prairie, Texas 75050.

Consumers with questions regarding this recall can contact our recall processor Inmar Pharmaceutical Services by phone at 1-855-249-3303, option 1; Monday – Friday (excluding holidays), 9:00 am – 5:00 pm, EST. 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.


Company Contact Information

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