# FDA recall D-0501-2017

> **G & W  Laboratories, Inc.** · Class II · drug recall initiated 2017-02-07.

## Product

Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43

## Reason for recall

Failed  Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.

## Distribution

Within United States

## Key facts

- **Recall number:** D-0501-2017
- **Recalling firm:** G & W  Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-07
- **Report date:** 2017-03-08
- **Termination date:** 2018-06-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2017

## Citation

> AI Analytics. FDA recall D-0501-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0501-2017. Source: US FDA. Licensed CC0.

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