PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products
April 25, 2007
Audience: Consumers, healthcare providers
[Posted 04/25/2007] FDA announced the entry
of a Consent Decree of Permanent Injunction against PharmaFab Inc.,
its subsidiary, PFab LP, and two company officials, to stop the
illegal manufacture and distribution of prescription and
over-the-counter drug products. The products are illegal because
they are not produced according to the required current good
manufacturing practice (CGMP) and many also lack required FDA
approval. Compliance with CGMP is necessary to ensure that drugs
have the requisite safety, identity, strength, quality, and
purity.
PharmaFab is a major contract manufacturer and distributor of more
than 100 different prescription and over-the-counter drug products,
including cough and cold products, ulcer treatments, and postpartum
hemorrhage products. Consumers who have products manufactured by
PharmaFab should consult with their physician.