Reported Jul 6, 2016 · Terminated
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle,…
Actavis Pharma Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Pharma Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 2.5 mL Bottle |
| 2 | 5 mL Bottle |
| 3 | 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC |
| 4 | 50383-0282-02 |
| 5 | 50383-282-05 |
| 6 | 50383-0282-10 |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 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 2 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 3 628398 Exp. 6/30/2016, 630495, Exp.10/31/ 2016, 630511, Exp. 10/31/2016 347361, Exp. 8/31/2017 - Amount recalled
- 447,150 Bottles
Where it was sold
- Nationwide
- PR
Why it was 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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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