Summary

Company announcement date:
FDA Publication Date:
Type of product:
Drugs

Reason for posting:

Description of the reason for the recall

N-Nitrosodimethylamine (NDMA) Impurity

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

Product Description

Metformin Hydrochloride Extended Release Tablets


company announcement

FOR IMMEDIATE RELEASE – 01/07/2022 – Cranford, New Jersey, Viona Pharmaceuticals Inc., voluntarily recall twenty-three (23) a lot of Metformin Hydrochloride Extended Release Tablets, USP 750 mg to consumer level. The reason for the recall is an out of specification (OOS) result observed for one lot of the product (M008132) test “N-nitrosodimethylamine (NDMA) (by GC-MS/MS)” at 17 months, 25°C/60% RH Samples long-term stability. In an abundance of caution, the company has decided to voluntarily recall 23 lots that we have determined have a valid shelf life in the US market. 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 may cause cancer) based on laboratory test results. NDMA is a known environmental contaminant and is 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 medications and to contact their physician for advice regarding alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without talking to their healthcare professionals first. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-annonces-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 alongside 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. The recalled batches Metformin Hydrochloride Extended 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 Extended Release Tablets, USP 750 mg has been distributed At national scale at Distributors.

Product Name : Metformin Hydrochloride Extended Release Tablets, USP 750 mg
NDC: 72578-036-01
Sr. No. Lot. 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
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

Viona Pharmaceuticals Inc., notify his clients by email and mail (FedEx Overnight) and organize the come back of all recalled products to our recall processor at the following address

Inmar Pharmaceuticals Services-Recalls
3845 Great Lakes Road,
Grande Prairie, Texas 75050.

Consumers with questions regarding this recall may contact our recall processor Inmar Pharmaceutical Services by phone at 1-855-249-3303, Option 1; Monday through Friday (excluding holidays), 9:00 a.m. to 5:00 p.m. EST. Consumers should contact their doctor or health care provider if they have experienced 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 issues regarding recalled products should contact Viona Pharmaceuticals Inc., by phone at: 888-304-5011, Monday through Friday, 8:30 a.m. to 5:30 p.m. 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 the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178

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


Company details

Consumers:
Inmar Pharmaceutical Services


Product pictures