# FDA recall D-1113-2019

> **LUPIN SOMERSET** · Class II · drug recall initiated 2019-03-19.

## Product

Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19  UPC 343386050192    a) Lemon Flavor Pack net wt. 2 g UPC 343386200023  b) Orange Flavor Pack net wt. 2 g UPC 343386202027  c) Cherry Flavor Pack net wt. 2 g UPC 3433862034

## Reason for recall

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1113-2019
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-19
- **Report date:** 2019-04-17
- **Termination date:** 2022-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1113-2019

## Citation

> AI Analytics. FDA recall D-1113-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-1113-2019. Source: US FDA. Licensed CC0.

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