FDA recall D-0875-2022
Lupin Pharmaceuticals Inc. · Class II · drug
Product
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Reason for recall
Failed Stability Specification
Distribution
Product was distributed nationwide, including Puerto Rico.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-27
- Report date
- 2022-05-25
- Termination date
- 2023-04-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Baltimore, MD, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2022