FDA recall D-0350-2024

Product

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Distribution

Nationwide in the U.S.

Key facts

Status

Ongoing

Initiation date

2024-02-05

Report date

2024-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2024