LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somer…

Recall date

December 21, 2018

Source

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

Recall number

D-0346-2019

FDA classification

Class II

Brand / firm

LUPIN SOMERSET

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.

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, NDC 43386-450-11.