Recall: Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only

Product Detail

Product Description 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.

Recall Number D-852-2013

Classification Class II

Code Info Lot #: JX1877, Exp 06/13

Product Distributed Qty 50,982 bottles

Reason For Recall 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.

Event Detail

Event Id 65882

Product Type Drugs

Status Ongoing

Recalling Firm

Apotex Inc

City Richmond Hill
State
Country CA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-25

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide