Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-852-2013

June 25, 2013

Class II

Product summary

Firm
Apotex Inc
Event
Event 65882
Status
Terminated
Classification
Class II
Quantity
50,982 bottles
Official record key
drug-enforcement:D-852-2013

Official wording

Reason: 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.

Code information: Lot #: JX1877, Exp 06/13

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility