Denton Pharma, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0057-2021Class IIMetformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 October 8, 2020
D-0056-2021Class IIMetformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap LaOctober 8, 2020
D-0795-2020Class IIRanitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70December 20, 2019
D-0794-2020Class IIRanitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 709December 20, 2019