West-Ward Recalls Subpotent Ethambutol Hydrochloride Tablets
West-Ward Pharmaceutical Corp. is recalling 3,061 bottles of Ethambutol Hydrochloride Tablets due to out-of-specification assay results.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant health risks.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling 3,061 bottles of Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle. The product is manufactured for Versapharm Incorporated and carries the NDC 61748-011-01. The specific lot affected is 68028A with an expiration date of 07/14.
The recall was initiated because the drug failed to meet specification requirements for assay at the 24-month stability time-point, rendering the product subpotent. This means the tablets may not contain the full labeled amount of the active ingredient.
The affected product was distributed nationwide. Patients and healthcare providers should stop using the recalled lot and contact their healthcare provider or pharmacist for a replacement or alternative treatment.
The recalled product
- Product
- Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
- 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 (2)
- Lot #: 68028A
- Exp 07/14
Distribution
Distributed nationwide across the United States.
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