West-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure
West-Ward Pharmaceuticals is recalling specific lots of Phenobarbital Tablets because they failed to meet dissolution specifications at the 12-month stability time point.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute hazard like a high-risk pathogen or structural defect.
Plain-English summary
West-Ward Pharmaceuticals Corp. is recalling Phenobarbital Tablets, USP 60mg, 100-count bottles. The recall is limited to Lot #71294A with an expiration date of 5/2017. The product is distributed nationwide.
The recall was initiated because the tablets failed to meet dissolution specifications at the 12-month stability time point. This means the medication may not dissolve in the body as intended, potentially affecting its therapeutic performance.
Patients and healthcare providers should check their medication for the specific lot number and expiration date listed above. If the medication matches the recalled lot, it should be returned to the pharmacy or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- PHENOBARBITAL (PHENOBARBITAL)
- Brand
- PHENOBARBITAL
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
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 #: 71294A
- Exp. 5/2017
Distribution
Distributed nationwide across the United States.
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