West-Ward Recalls Isoniazid Tablets Due to Dissolution Failure
West-Ward Pharmaceutical Corp. is recalling Isoniazid Tablets, USP, 300 mg because stability lots failed to meet dissolution specifications.
What this means for you
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, and the hazard involves a failure to meet dissolution specifications without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling Isoniazid Tablets, USP, 300 mg, which are prescription-only medications. The recall covers specific 100-count, 1,000-count, and 30-count bottles manufactured by West-Ward and distributed nationwide.
The recall was initiated because stability lots for the affected products cannot support dissolution past the 36-month time point, meaning they failed to meet required dissolution specifications. This defect may affect the drug's performance or efficacy.
Consumers and healthcare providers should stop using the affected Isoniazid Tablets and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The specific lot numbers and expiration dates are detailed in the official recall notice.
The recalled product
- Product
- Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Antibiotic
- 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 (11)
- Lot #: a) 67839A
- 67839D
- Exp 05/14
- 67936A
- Exp 02/15
- b) 67839B
- 67840C
- 67936B
- c) 67840A
- d) 67840B
- e) 67839C
Distribution
Distributed nationwide across the United States.
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