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
Reported: July 6, 2016 Initiated: March 16, 2016 #D-1060-2016
Product Description
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
Reason for Recall
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).
Details
- Recalling Firm
- Actavis Pharma Inc
- Units Affected
- 447,150 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Actavis Pharma Inc. Units affected: 447,150 Bottles.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2016. Severity: Low. Recall number: D-1060-2016.
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