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.

All sterile products within expiry Recalled by Unique Pharmaceutical, Ltd Due to Lack of Sterility Assurance: A recent FDA inspection...

Date: July 18, 2014
Company: Unique Pharmaceutical, Ltd
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 Unique Pharmaceutical, Ltd directly.

Affected Products

All sterile products within expiry

Quantity: 325,225 units (syringes, vials, bags)

Why Was This Recalled?

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Unique Pharmaceutical, Ltd

Unique Pharmaceutical, Ltd has 3 total recalls tracked by RecallDetector.

Related Recalls

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