Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Histamine Recalled by Triangle Compounding Due to Lack of Assurance of Sterility:The product lots are...

Date: September 6, 2013
Company: Triangle Compounding
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Triangle Compounding directly.

Affected Products

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

Quantity: 8 vials

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: NC

Affected (1 state)Not affected

About Triangle Compounding

Triangle Compounding has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report