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LUPIN SOMERSET Recalls
13 recalls on record · June 6, 2018 to May 1, 2019 · Drugs
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
April 17, 2019DrugsFDA
LUPIN SOMERSET recalls Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufacture
Hazard: Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
January 30, 2019DrugsFDA
LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
January 9, 2019DrugsFDA
LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somers
Hazard: Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
October 31, 2018DrugsFDA
LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore,
Hazard: Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
September 26, 2018DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. S
Hazard: Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
July 18, 2018DrugsFDA
LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset
Hazard: Subpotent Drug and Failed Content Uniformity.
July 11, 2018DrugsFDA
LUPIN SOMERSET recalls Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (ND
Hazard: Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
June 6, 2018DrugsFDA
LUPIN SOMERSET recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel La
Hazard: Labeling: Missing Label