Medisca patients with UCD. In response to the violations,

Medisca
Pharmaceutique Incorporation supplies pharmacy compounding products such as
active pharmaceutical ingredients (API) and excipients for sale and distribution
in hospitals and compounding pharmacies. Medisca repackages L-Citrulline, an
active pharmaceutical ingredient essential for the treatment of urea cycle
disorder (UCD), a rare genetic disorder that results in the deficiency of
enzymes critical for the removal of ammonia from the body.

 

Following reports from
healthcare professionals about adverse effects experienced by patients with UCD
taking L-Citrulline from Medisca, the Food and Drug Administration (FDA)
carried out an inspection on the company on 17 February 2014. The FDA’s inspection
observed that several batches of L-Citrulline were adulterated, as the
strength, purity and quality of the L-Citrulline samples fall below the its standards
as indicated on the L-Citrulline labels. The samples of L-Citrulline were then analysed
and determined to be N-Acetyl-Leucine, a drug that was used for vertigo
treatment. This analysis concluded that Medisca has violated the FDA Code of
Federal Regulations (CFR), 21 CFR §351(c),
on the misrepresentation of strength.

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In addition, the FDA’s
inspection observed that the labelling of the L-Citrulline was false and
misleading. Samples of API that were labelled as L-Citrulline were analysed and
determined to be N-Acetyl-Leucine, hence concluded that Medisca has violated
the 21 CFR §352(a) for false or
misleading label.

 

Consequently, the usage
of the adulterated and mislabelled L-Citrulline caused patients with UCD to
suffer from high levels of ammonia in their bodies, which resulted in
developmental disabilities, brain damage, coma and death of the patients with
UCD.

 

In response to the
violations, FDA has recommended healthcare providers to stop dispensing
L-Citrulline from the 8 batches of adulterated L-Citrulline and to return all
unused L-Citrulline stocks to Medisca. Patients were recommended to stop using
L-Citrulline from Medisca and direct any healthcare concerns to their
healthcare professionals. The sale and usage of L-Citrulline from Medisca was
terminated until FDA approved the corrective actions carried out by Medisca to
correct the adulterated and misleading labels of L-Citrulline.

 

In addition, Medisca
received warning letters from the FDA about the adulterated L-Citrulline and
its misleading labels. Medisca then recalled and investigated 8 batches of L-Citrulline
and determined that none of the 8 batches contained L-Citrulline. Additionally,
Medisca discovered the mix-up of L-Citrulline with N-Acetyl-Leucine was caused
by the failure to verify the identity of products Medisca purchased from a
manufacturer.

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