FDAFDA · Food and drugs·Recall number D-0514-2017
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
Published March 15, 2017 · Recall initiated: February 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide
- Lot
- Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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