Product: 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).
Recall initiated: 20160316
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated