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.
Reported: July 6, 2016 Initiated: June 10, 2016 #D-1059-2016
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.
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 958 Bottles
- Distribution
- US Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 958 Bottles.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2016. Severity: Low. Recall number: D-1059-2016.
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