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.

Recall Number: D-0346-2019

Firm: LUPIN SOMERSET

Classification: Class II

Status: Terminated

Report Date: 20190109

Initiation Date: 20181221

Termination Date: 20230315

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

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.