← DrugSupply
HomeDrug Supply Records

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620 Supply Disruption — Teva Pharmaceuticals USA (Mod

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620 Supply Disruption — Teva Pharmaceuticals USA (Mod is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620; Manufacturer: Teva

Drug nameMetformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620
ManufacturerTeva Pharmaceuticals USA
Recall/Disruption reasonCGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Risk classificationModerate Risk — Temporary Health Consequence
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-1331-2020
Initiation date20200602
Quantity affecteda) 92,793 bottles and b) 4,824 bottles
Dosage formDrugs

🔍 Search all drug supply records →