FDA (Drugs) recall action 65445
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because they contain a trace amount of Methocarbamol.
West-Ward Pharmaceutical Corp. is recalling specific lots of Belladonna Alkaloids with Phenobarbital Tablets due to the presence of black specks comprised of degraded organic material.