December 2021 FDA Recall Metformin Hydrochloride by Viona Pharmaceuticals Inc (D-0392-2022 - CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.)
This Class II drug recall was voluntarily initiated by Viona Pharmaceuticals Inc on December 27, 2021 for the product Metformin Hydrochloride. The FDA reported the reason for recall as cgmp deviations- detection of n-nitrosodimethylamine (ndma) levels in excess of the acceptable daily intake limit.. The product was distributed in Product was distributed to 17 wholesalers who further distributed the product to 85 locations. and the recall is currently terminated.
Recall Number: D-0392-2022
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
12-27-2021
02-02-2022
23,8416/100 count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
VIONA PHARMACEUTICALS INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
09-20-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Batch or Lot Expiration Information
Lot# M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
