D-1059-2016 Class III Terminated
FDA drug recall D-1059-2016 was initiated by Valeant Pharmaceuticals North America LLC on June 10, 2016 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. The recall status is terminated (terminated June 14, 2017). Affected quantity: 958 Bottles.
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.