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.

Recall Number: D-1059-2016

Firm: Valeant Pharmaceuticals North America LLC

Classification: Class III

Status: Terminated

Report Date: 20160706

Initiation Date: 20160610

Termination Date: 20170614

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

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.