# FDA recall D-1069-2013

> **Triangle Compounding** · Class II · drug recall initiated 2013-09-06.

## Product

Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.

## Reason for recall

Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

## Distribution

NC

## Key facts

- **Recall number:** D-1069-2013
- **Recalling firm:** Triangle Compounding
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-06
- **Report date:** 2013-10-09
- **Termination date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cary, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1069-2013

## Citation

> AI Analytics. FDA recall D-1069-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1069-2013. Source: US FDA. Licensed CC0.

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