Reported Aug 14, 2013 · Terminated
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by
Apotex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc · 380 Elgin Mills Rd East · Richmond Hill, N/A · N/A
Is this the product you have?
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Apotex Inc., Toronto, Ontario Canada M9L 1T9 |
| 2 | Manufactured for: Apotex Corp., Weston, FL 33326 |
| 3 | NDC 60505-0565-1 |
| 4 | UPC 3 60505 05651 4. |
- Lot codes and dates
Lot #: JX1877Exp 06/13
- Amount recalled
- 50,982 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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