D-1059-2016 Class III Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
July 6, 2016
Initiation Date
June 10, 2016
Termination Date
June 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
958 Bottles

Product Description

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 Pattern

US Nationwide

Code Information

Lot #: 2555979, Expiry: 09/2016.