GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

FDA recall notice · announced May 25, 2022 · Lupin Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Product was distributed nationwide, including Puerto Rico.
Lot/code information: Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Quantity: 26,910 bottles
Status: Terminated
Products in this recall event:
- GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19 (D-0875-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.