Somerset, NJ, United States
Novel Laboratories, Inc. recalls
1 recall recorded since 2018, most recently on 5 March 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 5 March 2018
- Terminated
- 8 June 2020
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0599-2018
- Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD
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.