Home / Recalls / VIONA PHARMACEUTICALS INC / D-0640-2021

D-0640-2021 Class II Terminated

Recalled by VIONA PHARMACEUTICALS INC — Cranford, NJ

Recall Details

Product Type
Drugs
Report Date
June 30, 2021
Initiation Date
June 1, 2021
Termination Date
May 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21240 bottles

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01

Reason for Recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Distribution Pattern

Nationwide in the US

Code Information

Lot M915601 & M915602, Oct 2021

Other recalls by VIONA PHARMACEUTICALS INC

  • D-0016-2026 Class II — Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Li (October 6, 2025)
  • D-0595-2025 Class II — Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use (August 12, 2025)
  • D-0171-2025 Class II — Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Aheme (December 10, 2024)
  • D-0172-2025 Class II — Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmed (December 10, 2024)
  • D-0038-2025 Class II — Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd (October 29, 2024)
  • D-0011-2025 Class II — Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd (September 24, 2024)
  • D-0392-2022 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bot (December 27, 2021)