LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerse…

Recall date

June 28, 2018

Source

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

Recall number

D-0927-2018

FDA classification

Class II

Brand / firm

LUPIN SOMERSET

Sold / distributed

Nationwide within the US

Why it was recalled

Subpotent Drug and Failed Content Uniformity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11