The Recall Desk
ModerateFDA (Drugs)·D-883-2013·Announced 2013-08-21

West-Ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance

West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because black specks of degraded organic material were found on the tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (degraded organic material) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

West-Ward Pharmaceutical Corp. is voluntarily recalling Belladonna Alkaloids with Phenobarbital Tablets, 1000 count and 5000 count PET bottles, due to the presence of a foreign substance. The recall involves specific lots of the prescription-only medication manufactured in Eatontown, N.J.

The recall was initiated because black specks comprised of degraded organic material were found on the tablets. The affected products are distributed nationwide.

Consumers with these specific products should stop using them and contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
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.

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 (11)

  • 1000's: Catalog #1140-10
  • Lot #/Expiry Dates: 67328A
  • 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 Dates: 68064A/Jan 2015 and 68666A/May 2015.

Distribution

Distributed nationwide across the United States.