Valeant Recalls Secobarbital Sodium Capsules Due to Missing Anaphylaxis Warning
Valeant Pharmaceuticals is recalling 958 bottles of SECONAL SODIUM capsules because the package insert is missing a warning regarding anaphylaxis.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a missing warning label rather than a direct physical hazard or contamination.
Plain-English summary
Valeant Pharmaceuticals North America, LLC is recalling 958 bottles of SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles. The product is distributed by Valeant Pharmaceuticals North America, LLC, located in Bridgewater, NJ, and carries the NDC 0187-4220-10. The specific lot number is 2555979, with an expiry date of 09/2016.
The recall was initiated due to a labeling error where the package insert is missing a warning regarding anaphylaxis. This omission means that patients and healthcare providers may not be fully informed of this specific potential adverse reaction.
The affected product was distributed US Nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiry date. If found, the product should be returned to the pharmacy or distributor for replacement or refund, and patients should consult their healthcare provider regarding any concerns.
The recalled product
- 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.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 958
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 2555979
- Expiry: 09/2016.
Distribution
Distributed nationwide across the United States.
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