Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Check against the official notice below — it lists the full affected range.
Viona Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg in 100-count bottles due to the detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The affected product has NDC# 72578-036-01 and includes 23 specific lot codes manufactured between June 2022 and January 2023. Approximately 238,416 bottles were distributed through 17 wholesalers to 85 locations.
The recall source does not specify what consumers should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason for recall: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Distribution: Product was distributed to 17 wholesalers who further distributed the product to 85 locations. Quantity: 23,8416/100 count bottles Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.