Drug product
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
D-0514-2017
Product summary
- Firm
- Actavis Inc
- Event
- Event 76421
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14280 bottles
- Official record key
drug-enforcement:D-0514-2017
Official wording
Reason: Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Code information: Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.