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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: JX1877, Exp 06/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-852-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 25, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 50,982 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc
Original FDA data
Every field from FDA enforcement report D-852-2013, exactly as published.
Show all FDA fields
- City
- Richmond Hill
- Status
- Terminated
- Country
- Canada
- Event ID
- 65882
- Address
- 380 Elgin Mills Rd East
- Code information
- Lot #: JX1877, Exp 06/13
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-852-2013
- Classification
- Class II
- Recalling firm
- Apotex Inc
- Product quantity
- 50,982 bottles
- Termination date
- Apr 18, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 25, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2013