# FDA recall D-0875-2022

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2022-04-27.

## 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

- **Recall number:** D-0875-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2022

## Citation

> AI Analytics. FDA recall D-0875-2022. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0875-2022. Source: US FDA. Licensed CC0.

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