Recalls / Class III
Class IIID-0502-2024
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
- Brand name
- Xelpros
- Generic name
- Latanoprost
- Active ingredient
- Latanoprost
- Route
- Ophthalmic, Topical
- NDC
- 47335-317
- FDA application
- NDA206185
- Affected lot / code info
- Lot #: HAD3383A, Exp 8/31/2024
Why it was recalled
Failed Release Testing: Out of specification for particulate matter test.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 35,069 bottles
- Distribution pattern
- TX, PA
Timeline
- Recall initiated
- 2024-04-22
- FDA classified
- 2024-05-20
- Posted by FDA
- 2024-05-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0502-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.