Why it was recalled
Failed Release Testing: Out of specification for particulate matter test.
Product description
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Lot numbers, UPCs & expiration codes
Lot #: HAD3383A, Exp 8/31/2024
Where it was sold
TX, PA
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-0502-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 22, 2024
- FDA report date
- May 29, 2024
- Quantity
- 35,069 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0502-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94465
- Address
- 2 Independence Way
- Code information
- Lot #: HAD3383A, Exp 8/31/2024
- Postal code
- 08540-6620
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0502-2024
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 35,069 bottles
- Reason for recall
- Failed Release Testing: Out of specification for particulate matter test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
- Distribution pattern
- TX, PA
- Recall initiation date
- Apr 22, 2024
- Initial firm notification
- Letter
- Center classification date
- May 20, 2024