Somerset, NJ, United States
Novel Laboratories, Inc. d.b.a LUPIN recalls
1 recall recorded since 2018, most recently on 29 July 2021. 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 II Drugs
- Recall started
- 29 July 2021
- Terminated
- 14 November 2022
- Reason
- Failed Stability Specification; Out of specification for Osmolarity
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0726-2021
- GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 N
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.