Seconal Sodium recall: Labeling Error
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.
Why was Seconal Sodium recalled?
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 2555979, Expiry: 09/2016.
- 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.
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Quantity
- 958 Bottles
- Distribution
- US Nationwide
- Recall date
- July 6, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)