FDA recall D-852-2013

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.

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-06-25

Report date

2013-08-14

Termination date

2016-04-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond Hill, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-852-2013