Denton Pharma Recalls
4 recalls on record · January 29, 2020 to November 11, 2020 · Drugs
November 11, 2020DrugsFDA
Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
January 29, 2020DrugsFDA
Denton Pharma, Inc. recalls Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
Denton Pharma, Inc. recalls Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-c
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.