Apotex Inc recalls Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto,
Recalled August 14, 2013 · FDA recall D-852-2013 · Apotex
Hazard
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date. · FDA Class II
Units
50,982 bottles
Sold at
Nationwide
Description
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Product
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
Manufacturer(s)
Apotex Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →