Terconazole Vaginal Suppositories Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling Terconazole Vaginal Suppositories (batch 1014228A) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
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: This is an FDA Class II recall initiated due to a CGMP temperature exposure deviation. No illnesses, injuries, or adverse events have been reported. The hazard is theoretical, based on a manufacturing compliance issue rather than documented product failure or patient harm.
Plain-English summary
Cardinal Healthcare is recalling Terconazole Vaginal Suppositories, 80 mg (batch 1014228A), which were distributed nationwide. The product is manufactured by Cosette Pharmaceuticals, Inc., located at 111 Coolidge Street, South Plainfield, NJ 07080.
The recall was initiated because products in this batch were exposed to temperatures outside the conditions specified on the product label. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards.
Consumers who possess the affected product should contact their pharmacy or healthcare provider with questions about their supply.
The recalled product
- Product
- TERCONAZOLE (TERCONAZOLE)
- Brand
- TERCONAZOLE
- Manufacturer
- CARDINAL HEALTHCARE
- Affected units
- 1
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 (1)
- Batch 1014228A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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