FDA (Drugs) recall action 75650
The FDA (Drugs) publishes a recall like this one as 11 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 11 pages.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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.
VistaPharm is recalling specific lots of Metoclopramide Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Oxycodone Hydrochloride Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Lactulose Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Lactulose Solution USP because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Phenytoin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
VistaPharm is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.