Valeant Pharmaceuticals North America LLC recalls SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceu…
- Recall date
- June 10, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1059-2016
- FDA classification
- Class III
- Brand / firm
- Valeant Pharmaceuticals North America LLC
- Sold / distributed
- US Nationwide
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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