FDA Recall D-0502-2024
SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ
Class III Ongoing 752 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Release Testing: Out of specification for particulate matter test.
Recall record
- Recall number
D-0502-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- TX, PA
- Recall initiated
- 2024-04-22
- Classified by FDA Center
- 2024-05-20
- FDA published
- 2024-05-29
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- XELPROS
- Generic name(s)
- LATANOPROST
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
47335-317- Route(s)
- OPHTHALMIC, TOPICAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.