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

FDA recall notice · announced March 15, 2017 · Actavis

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

Notes

Distribution: Nationwide
Lot/code information: Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Quantity: 14280 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.