Class III โ€” Low Risk

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

Ofloxacin Ophthalmic Solution Recalled by PACK Pharmaceuticals, LLC Due to Defective Container: Stability samples of both products were...

Date: September 9, 2013
Company: PACK 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 PACK Pharmaceuticals, LLC directly.

Affected Products

Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

Quantity: 126 bottles

Why Was This Recalled?

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PACK Pharmaceuticals, LLC

PACK Pharmaceuticals, LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

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