West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures
West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.
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 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 III, which the rubric indicates is typically a score of 1 or 2. Given the presence of chemical impurities, a score of 2 (Moderate) is appropriate as it is not merely cosmetic or documentation-related, but the agency classification limits the severity.
Plain-English summary
West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, NDC 0054-0415-25. The recall involves 3,336 bottles of the medication, which were distributed nationwide in the US. The specific lot affected is AA4424A, with an expiration date of 07/31/2020.
The recall was initiated because the product failed to meet impurities and degradation specifications. Specifically, the tablets were found to be out of specification for impurity 6 and total degradants.
Consumers and healthcare providers should check their inventory for this specific NDC and lot number. If found, the product should be returned to the distributor or disposed of according to local regulations. This is a prescription-only medication.
The recalled product
- Product
- Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug — Tablets
- Hazard
- Affected units
- 3,336
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 #: AA4424A
- Exp. 07/31/2020
Distribution
Distributed nationwide across the United States.
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