Somerset, NJ, United States
LUPIN SOMERSET recalls
9 recalls recorded since 2018, most recently on 10 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)0
Terminated or completed9
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 10 April 2019
- Terminated
- 14 October 2022
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1245-2019, D-1246-2019, D-1247-2019, D-1243-2019, D-1244-2019
- Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-
- Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543
- Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01
- Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-
Terminated Class II Drugs
- Recall started
- 19 March 2019
- Terminated
- 23 May 2022
- Reason
- Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1113-2019
- Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltim
Terminated Class II Drugs
- Recall started
- 15 January 2019
- Terminated
- 17 February 2023
- Reason
- 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.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0390-2019
- Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-06
Terminated Class II Drugs
- Recall started
- 21 December 2018
- Terminated
- 15 March 2023
- Reason
- Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0346-2019
- Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11
Terminated Class II Drugs
- Recall started
- 5 October 2018
- Terminated
- 8 November 2022
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0092-2019
- Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Terminated Class III Drugs
- Recall started
- 23 August 2018
- Terminated
- 14 October 2022
- Reason
- 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.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1214-2018
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-
Terminated Class II Drugs
- Recall started
- 28 June 2018
- Terminated
- 6 March 2023
- Reason
- Subpotent Drug and Failed Content Uniformity.
- Distribution
- Nationwide within the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0927-2018
- Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, N
Terminated Class III Drugs
- Recall started
- 13 June 2018
- Terminated
- 2 February 2021
- Reason
- Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0907-2018
- Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonvi
Terminated Class III Drugs
- Recall started
- 24 May 2018
- Terminated
- 26 January 2021
- Reason
- Labeling: Missing Label
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0836-2018
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 2120
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.