Reported Nov 5, 2014 · Terminated

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for…

West-Ward Pharmaceutical Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: West-Ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #68975A
    • #68976
    • Exp. 07/15
Amount recalled
5,596 HDPE bottles

Where it was sold

Why it was recalled

Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 3, 2015 · Data as of Sep 19, 5:56 PM UTC

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