April 2024 FDA Recall Xelpros by Sun Pharmaceutical Industries Inc
D-0502-2024 - Failed Release Testing
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on April 22, 2024 for the product Xelpros. The FDA reported the reason for recall as failed release testing. The product was distributed in TX, PA and the recall is currently ongoing.
Recall Number: D-0502-2024
Failed Release Testing: Out of specification for particulate matter test.
04-22-2024
05-29-2024
35,069 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX, PA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : HAD3383A, Exp 8/31/2024
