Class III โ€” Low Risk

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

Tobramycin Ophthalmic Oint. Recalled by Stat Rx USA Due to Labeling: Label Mix-up: The affected units were labeled...

Date: June 18, 2012
Company: Stat Rx USA
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 Stat Rx USA directly.

Affected Products

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

Quantity: 22 units

Why Was This Recalled?

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Where Was This Sold?

This product was distributed to 3 states: FL, PA, VA

Affected (3 states)Not affected

About Stat Rx USA

Stat Rx USA has 4 total recalls tracked by RecallDetector.

Related Recalls

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