FDA recall D-0927-2018

Product

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

Reason for recall

Subpotent Drug and Failed Content Uniformity.

Distribution

Nationwide within the US

Key facts

Status

Terminated

Initiation date

2018-06-28

Report date

2018-07-18

Termination date

2023-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0927-2018