FDA recall D-0346-2019

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, NDC 43386-450-11.

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-12-21

Report date

2019-01-09

Termination date

2023-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2019