FDAJune 10, 2016drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
What to do
FDA enforcement status: Terminated
Brands named
valeant pharmaceuticals north americavaleantvaleant pharmaceuticals
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-2...2026-05-29
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