D-0514-2017 Class III Terminated
FDA drug recall D-0514-2017 was initiated by Actavis Inc on Feb 7, 2017 and is designated Class III. Reason for recall: Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. The recall status is terminated (terminated Jan 9, 2018). Affected quantity: 14280 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 15, 2017
- Initiation Date
- Feb 7, 2017
- Termination Date
- Jan 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14280 bottles
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
Reason for recall
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Distribution pattern
Nationwide
Code information
Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0514-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026