LUPIN SOMERSET

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1246-2019Class IIIMorphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: NoveApril 10, 2019
D-1244-2019Class IIIMorphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: NovelApril 10, 2019
D-1245-2019Class IIIMorphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: NovelApril 10, 2019
D-1243-2019Class IIIMorphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: NovelApril 10, 2019
D-1247-2019Class IIIMorphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel LaboratApril 10, 2019
D-1113-2019Class IIGavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, March 19, 2019
D-0390-2019Class IIFluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: LupinJanuary 15, 2019
D-0346-2019Class IINitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel LaboraDecember 21, 2018
D-0092-2019Class IIFluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin PharmaceutiOctober 5, 2018
D-1214-2018Class IIIMorphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel August 23, 2018
D-0927-2018Class IINitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel LaboratJune 28, 2018
D-0907-2018Class IIIEquate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged inJune 13, 2018
D-0836-2018Class IIIHydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, ManufMay 24, 2018