Class III
Terminated
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
- Company
- Actavis Inc
- Recall Initiated
- February 7, 2017
- Posted
- March 15, 2017
- Recall Number
- D-0514-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14280 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Distribution
Nationwide
Lot / Code Info
Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
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