Welcome Overview Drug cGMPs in Action cGMP Enforcement Resources About This Site Welcome
Images of a pharmaceutical facility
Welcome

Recall
- - -
o cGMP enforcement
o Inspections
o Adulteration
o FDA 483
o Recall
o Warning Letter
o Border Alerts
o License Suspension or Revocation
o Seizure
o Consent Decree
o Criminal Prosecution

This site brought to you by
LearningPlus, Inc.
as a service to the pharmaceutical manufacturing industry

Recalls are "voluntary" actions made by the firm to remove products from the market. FDA cannot recall drugs, however they can "suggest" to firms that they take action on "violative" products. The FDA has three classes of recalls: I, II, and III with Class I being the most serious.

FDA report of a recall initiated by Alpha Therapeutic Corporation
Image close page