FDA recall D-1059-2016

Product

SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.

Reason for recall

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-10

Report date

2016-07-06

Termination date

2017-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2016