Class III — Low Risk

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

Ciprofloxacin Ophthalmic Solution (0.3% as base) Recalled by Actavis Pharma Inc Due to Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due...

Name: Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701
Brand: Actavis Pharma Inc

Date: March 16, 2016

Company: Actavis Pharma Inc

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 Actavis Pharma Inc directly.

Affected Products

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

Quantity: 447,150 Bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

About Actavis Pharma Inc

Actavis Pharma Inc has 1 total recall tracked by RecallDetector.

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