West-Ward Recalls Ethambutol Hydrochloride Tablets Due to Stability Failure
West-Ward Pharmaceutical Corp. is recalling 5,596 bottles of Ethambutol Hydrochloride Tablets, USP, 100 mg, due to an out-of-specification stability result.
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, which typically involves a risk of temporary or medically reversible health consequences. The hazard is subpotency (reduced effectiveness) rather than a direct physical injury or acute toxicity, fitting the Moderate severity criteria for low-risk contamination or labeling/potency errors without reported illness.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling 5,596 HDPE bottles of VersaPharm Incorporated Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only. The affected product is identified by Lot #68975A and #68976, with an expiration date of 07/15. The product was distributed in Georgia (GA).
The recall was initiated because the product failed to meet potency specifications at the 36-month routine stability time point. This is classified as a subpotency issue, meaning the medication may not contain the full amount of the active ingredient required for effective treatment.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement or alternative treatment. The recall is limited to the specific lot numbers and expiration date listed above.
The recalled product
- Product
- VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 5,596
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)
- Lot #68975A
- #68976
- Exp. 07/15
Distribution
Distributed in 1 state:
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