Drug product
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
D-0502-2024
Product summary
- Event
- Event 94465
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 35,069 bottles
- Official record key
drug-enforcement:D-0502-2024
Official wording
Reason: Failed Release Testing: Out of specification for particulate matter test.
Code information: Lot #: HAD3383A, Exp 8/31/2024
Distribution pattern: TX, PA
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Potency or specification failure
Out of specification