Reported Apr 10, 2013 · Terminated

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm…

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?

  • Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd
  • forVersapharm Incorporated, Marietta, GA; Mfd
  • byWest-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01
Lot codes and dates
    • Lot #: 68028A
    • Exp 07/14
Amount recalled
3, 061 bottles

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

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 Dec 18, 2013 · Data as of Sep 19, 7:58 PM UTC

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