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Novel Laboratories, Inc. d.b.a Lupin Somerset

Novel Laboratories, Inc. d.b.a Lupin Somerset Recalls

All product recalls associated with Novel Laboratories, Inc. d.b.a Lupin Somerset.

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Recall Summary

Total Recalls

14

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–14 of 14 recalls

PEG-3350 Solution (Lupin) – Defective Container (2024)

Defective container: potential for non-sealed pouches which can lead to product leakage.

FDAJul 2, 2024Nationwide• Novel Laboratories, Inc. d.b.a Lupin Somerset

Morphine Sulfate 200mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate 60mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate 100mg Tablets (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate Tablets 15mg (Lupin Somerset) – Impurity Concern (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Morphine Sulfate Tablets 30mg (Lupin Somerset) – Impurity Concern (2019)

Failed Impurities/Degradation Specifications

FDAApr 10, 2019Nationwide• LUPIN SOMERSET

Gavilyte-N (Lupin Somerset) – Incorrect Flavor Labeling (2019)

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

Class IIModerate

FDAMar 19, 2019Nationwide• LUPIN SOMERSET

Fluocinolone Acetonide Solution (Lupin) – impurity specification (2019)

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.

Class IIModerate

FDAJan 15, 2019Nationwide• LUPIN SOMERSET

Nitrofurantoin Oral Suspension (Lupin) – Subpotent Drug (2018)

Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.

Class IIModerate

FDADec 21, 2018Nationwide• LUPIN SOMERSET

Fluocinolone Acetonide Solution (Lupin) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

Class IIModerate

FDAOct 5, 2018Nationwide• LUPIN SOMERSET

Morphine Sulfate Tablets (Lupin Somerset) – Impurity Specifications (2018)

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.

FDAAug 23, 2018Nationwide• LUPIN SOMERSET

Nitrofurantoin Oral Suspension (Lupin Somerset) – subpotent drug (2018)

Subpotent Drug and Failed Content Uniformity.

Class IIModerate

FDAJun 28, 2018Nationwide• LUPIN SOMERSET

Equate ClearLAX (LUPIN SOMERSET) – labeling issue (2018)

Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

FDAJun 13, 2018Nationwide• LUPIN SOMERSET

Hydrocodone Acetaminophen Tablets (Lupin Somerset) – Missing Label (2018)

Labeling: Missing Label

FDAMay 24, 2018OH• LUPIN SOMERSET