Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
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.
Lot numbers, UPCs & expiration codes
Lot #: 2555979, Expiry: 09/2016.
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1059-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 10, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 958 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1059-2016, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74532
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 2555979, Expiry: 09/2016.
- Postal code
- 08807-2867
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1059-2016
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 958 Bottles
- Termination date
- Jun 14, 2017
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jun 10, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2016