Recalls / Class III
Class IIID-0514-2017
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
- Affected lot / code info
- Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Why it was recalled
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 14280 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-07
- FDA classified
- 2017-03-09
- Posted by FDA
- 2017-03-15
- Terminated
- 2018-01-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0514-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.