FDA recall D-1030-2016

Nostrum Laboratories, Inc. · Class II · drug

Product

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-05-23
Report date: 2016-06-22
Termination date: 2017-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bryan, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2016