# FDA recall D-0346-2019

> **LUPIN SOMERSET** · Class II · drug recall initiated 2018-12-21.

## Product

Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ  08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, NDC 43386-450-11.

## Reason for recall

Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0346-2019
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-12-21
- **Report date:** 2019-01-09
- **Termination date:** 2023-03-15

- **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-0346-2019

## Citation

> AI Analytics. FDA recall D-0346-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0346-2019. Source: US FDA. Licensed CC0.

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