# FDA recall D-1484-2014

> **Novel Laboratories, Inc.** · Class III · drug recall initiated 2014-06-20.

## Product

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873.  Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.

## Reason for recall

Failed Impurity/Degradation Specification; 12-month stability time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1484-2014
- **Recalling firm:** Novel Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-06-20
- **Report date:** 2014-09-03
- **Termination date:** 2015-06-29

- **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-1484-2014

## Citation

> AI Analytics. FDA recall D-1484-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1484-2014. Source: US FDA. Licensed CC0.

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