# FDA recall D-1165-2014

> **Traxx International Corp** · Class II · drug recall initiated 2014-01-14.

## Product

Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001

## Reason for recall

Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1165-2014
- **Recalling firm:** Traxx International Corp
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-14
- **Report date:** 2014-03-26
- **Termination date:** 2017-09-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1165-2014

## Citation

> AI Analytics. FDA recall D-1165-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1165-2014. Source: US FDA. Licensed CC0.

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