# FDA recall D-0599-2018

> **Novel Laboratories, Inc.** · Class III · drug recall initiated 2018-03-05.

## Product

Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202   NDC 43386-118-03  UPC 343386118038

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0599-2018
- **Recalling firm:** Novel Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2018-03-21
- **Termination date:** 2020-06-08

- **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-0599-2018

## Citation

> AI Analytics. FDA recall D-0599-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0599-2018. Source: US FDA. Licensed CC0.

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