CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled
West-Ward Pharmaceutical is recalling Versapharm Incorporated Ethambutol Hydrochloride Tablets, USP, 100 mg, distributed in Georgia. The recall was initiated on 2 Oct 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0172-2015
- FDA event ID
- 69539
- Recalling firm
- West-Ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2014
- FDA classified
- 30 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Oct 2014 | Recall initiated by company | |
| 30 Oct 2014 | Classified by FDA | +28 days |
| 5 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
GA
Questions about this recall
Why was it recalled?
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Which lots are affected?
Lot #68975A, #68976; Exp. 07/15
Where was it sold?
GA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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