Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

CEFTRIAXONE for Injection USP Recalled by Aidarex Pharmaceuticals LLC Due to CGMP Deviations: Out of specification (OOS) intermediate in...

Date: June 1, 2016
Company: Aidarex Pharmaceuticals LLC
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 Aidarex Pharmaceuticals LLC directly.

Affected Products

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Quantity: 10

Why Was This Recalled?

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

Where Was This Sold?

This product was distributed to 2 states: GA, IN

Affected (2 states)Not affected

About Aidarex Pharmaceuticals LLC

Aidarex Pharmaceuticals LLC has 10 total recalls tracked by RecallDetector.

Related Recalls

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