Recalls / Class III
Class IIID-1059-2016
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.
- Affected lot / code info
- Lot #: 2555979, Expiry: 09/2016.
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 958 Bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2016-06-10
- FDA classified
- 2016-06-30
- Posted by FDA
- 2016-07-06
- Terminated
- 2017-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1059-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.