FDAFDA · Food and drugs·Recall number D-1060-2016
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
Published July 6, 2016 · Recall initiated: March 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Pharma Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #s: a) 626487, Exp. 3/31/2016, 628181, Exp. 6/30/2016, 629827, Exp. 9/30/2016, 630495, Exp. 10/31/2016, 632266, Exp. 2/28/2017, 633683 Exp. 4/30/2017, 347742, Exp. 09/30/2017; b) 626487, Exp. 3/31/2016, 627438, 628080, Exp. 5/31/2016, 628181, 628491, Exp. 6/30/2016, 628634, Exp. 7/31/2016, 629141 Exp. 8/31/2016, 629827, Exp. 9/30/2016, 630495, Exp. 10/31/2016, 631528, Exp. 12/31/2016, 632266, Exp. 2/28/2017, 347613, Exp. 9/30/2017, 348175, Exp. 10/31/2017; c) 628398 Exp. 6/30/2016, 630495, Exp.10/31/ 2016, 630511, Exp. 10/31/2016 347361, Exp. 8/31/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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