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).
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1060-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 16, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 447,150 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1060-2016, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 73778
- Address
- 400 Interpace Pkwy
- Code information
- 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
- Postal code
- 07054-1120
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1060-2016
- Classification
- Class III
- Recalling firm
- Actavis Pharma Inc
- Product quantity
- 447,150 Bottles
- Termination date
- Jun 13, 2018
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 16, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2016