Why it was recalled
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Product description
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Lot numbers, UPCs & expiration codes
Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Where it was sold
Nationwide
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-0514-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 7, 2017
- FDA report date
- Mar 15, 2017
- Quantity
- 14280 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-0514-2017, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76421
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
- Postal code
- 07054-1120
- Report date
- Mar 15, 2017
- Product type
- Drugs
- Recall number
- D-0514-2017
- Classification
- Class III
- Recalling firm
- Actavis Inc
- Product quantity
- 14280 bottles
- Termination date
- Jan 9, 2018
- Reason for recall
- Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2017