Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01);…

Recall date

November 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0257-2019

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide within the United States

Why it was recalled

Cross Contamination with Other Products

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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