Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Indi…
SUN PHARMACEUTICAL INDUSTRIES INC · Failed Release Testing: Out of specification for particulate matter test.
- Status
- Ongoing
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class III
- Product type
- Drugs
- Event ID
- 94465
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address 1
- 2 Independence Way
- Postal code
- 08540-6620
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- TX, PA
- Recall number
- D-0502-2024
- 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
- Product quantity
- 35,069 bottles
- Reason for recall
- Failed Release Testing: Out of specification for particulate matter test.
- Recall initiation date
- 20240422
- Center classification date
- 20240520
- Report date
- 20240529
- Code info
- Lot #: HAD3383A, Exp 8/31/2024
- Harmonized identifiers (openFDA)
- Application number
- NDA206185
- Brand name
- XELPROS
- Generic name
- LATANOPROST
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 47335-317
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC, TOPICAL
- Substance name
- LATANOPROST
- RxCUI
- 2056743, 2056748
- SPL ID
- 44b8ddc0-81dc-4613-bbe8-0da960cc179c
- SPL set ID
- 34ad5cf6-4df0-4104-bddd-4c7631133ded
- Package NDC
- 47335-317-90, 47335-317-98, 47335-317-92, 47335-317-94
- Is original packager
- true
- Nui
- N0000175454, M0017805
- Pharm class epc
- Prostaglandin Analog [EPC]
- Pharm class cs
- Prostaglandins [CS]
- UNII
- 6Z5B6HVF6O