D-0875-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 25, 2022
- Initiation Date
- April 27, 2022
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,910 bottles
Product Description
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 Pattern
Product was distributed nationwide, including Puerto Rico.
Code Information
Lot # S001132, exp. date July 2022 NDC # 43386-060-19