FDAFDA · Food and drugs·Recall number D-852-2013
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.
Published August 14, 2013 · Recall initiated: June 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Inc
- Distributor
- Nationwide
- Lot
- Lot #: JX1877, Exp 06/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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