D-0257-2019 Class III Terminated

Recalled by Sandoz Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
November 21, 2018
Initiation Date
November 2, 2018
Termination Date
October 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14366 bottles

Product Description

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 Pattern

Nationwide within the United States

Code Information

Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020