Denton Pharma recalls
FDA enforcement reports naming Denton Pharma, Inc. as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Nov 11, 2020
- Nov 11, 2020Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only…Drug · Denton Pharma, Inc.CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)Class II
- Nov 11, 2020Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-30…Drug · Denton Pharma, Inc.CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)Class II
- Jan 29, 2020Ranitidine Tablets, USP 150 mg , a)Drug · Denton Pharma, Inc.CGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Jan 29, 2020Ranitidine Tablets, USP 300 mg a)Drug · Denton Pharma, Inc.CGMP Deviations: Presence of NDMA impurity detected in product.Class II