D-0502-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2024
- Initiation Date
- April 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,069 bottles
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
Reason for Recall
Failed Release Testing: Out of specification for particulate matter test.
Distribution Pattern
TX, PA
Code Information
Lot #: HAD3383A, Exp 8/31/2024