FDA recall D-0257-2019

Product

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540

Reason for recall

Cross Contamination with Other Products

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-11-02

Report date

2018-11-21

Termination date

2020-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2019