Why it was recalled
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Product description
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Lot numbers, UPCs & expiration codes
Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Where it was sold
Nationwide and Puerto Rico
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-1439-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 30, 2012
- FDA report date
- Aug 8, 2012
- Quantity
- 119,794 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1439-2012, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 62574
- Address
- 150 Signet Drive
- Code information
- Lot #s: JN1060, JN1061, JN1062, Exp 06/12
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1439-2012
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 119,794 Bottles
- Termination date
- Sep 19, 2013
- Reason for recall
- Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 30, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2012