Ciprofloxacin Ophthalmic Solution recall: Impurity Out of Spec
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…
Why was Ciprofloxacin Ophthalmic Solution 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Actavis Pharma Inc
- Quantity
- 447,150 Bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- July 6, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)