Drug product
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
D-0875-2022
Product summary
- Event
- Event 90094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,910 bottles
- Official record key
drug-enforcement:D-0875-2022
Official wording
Reason: Failed Stability Specification
Code information: Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Distribution pattern: Product was distributed nationwide, including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Stability Specification