West-ward Recalls Isoniazid Tablets for Failed Dissolution Specifications
West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg due to failed dissolution specifications and a 36-month stability timepoint issue.
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 corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg, USP, Rx Only. The recall involves 77,531 bottles of the medication, which were manufactured for VersaPharm Incorporated. The affected products are identified by lot codes 67079A, 67079B, and 67079C, and were distributed in Georgia.
The recall was initiated because the tablets failed to meet dissolution specifications and had a 36-month stability timepoint issue. Dissolution specifications ensure that the medication breaks down properly in the body to be absorbed effectively. A failure in this process may mean the medication does not work as intended.
Consumers who have these specific bottles of Isoniazid Tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Antibiotic
- Affected units
- 77,531
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 (3)
- 67079A
- 67079B
- 67079C
Distribution
Distributed in 1 state:
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