Reported Aug 21, 2013 · Terminated

Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET…

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?

  • Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Lot codes and dates
  • 1000's: Catalog #1140-10; Lot #/Expiry
  • Dates67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry
  • Dates68064A/Jan 2015 and 68666A/May 2015
Amount recalled
1000 count bottles/61,370 and 5000 count bottles/321

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

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 Jun 23, 2014 · Data as of Sep 19, 7:11 PM UTC

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