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.
Recall initiated: 20160610
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated