Latanoprost Ophthalmic Solution recall: Sterility Concern
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…
Why was Latanoprost Ophthalmic Solution 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JX1877, Exp 06/13
- 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…
- Recalling firm
- Apotex Inc
- Quantity
- 50,982 bottles
- Distribution
- Nationwide
- Recall date
- August 14, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)