Drug 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.
D-1059-2016
Product summary
- Event
- Event 74532
- Status
- Terminated
- Classification
- Class III
- Quantity
- 958 Bottles
- Official record key
drug-enforcement:D-1059-2016
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Code information: Lot #: 2555979, Expiry: 09/2016.
Distribution pattern: US Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing