FDA recall D-0262-2019

Sandoz Inc · Class III · drug

Product

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01

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-0262-2019