FDA recall D-0597-2024

Product

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA and Puerto rico

Key facts

Status

Terminated

Initiation date

2024-07-09

Report date

2024-07-24

Termination date

2025-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2024