MediscaPharmaceutique Incorporation is a supplier of pharmacy compounding productssuch as active pharmaceutical ingredients (API) and excipients. Mediscarepackages L-Citrulline, an active pharmaceutical ingredient, for distributionand sale to hospitals and compounding pharmacies. L-Citrulline is an essentialdrug critical for the treatment of urea cycle disorder (UCD), a rare geneticdisorder that causes people to be unable to produce essential enzymes for theremoval of ammonia from the body. Following reports fromhealthcare professionals about adverse effects experienced by patients with UCDtaking L-Citrulline from Medisca, the Food and Drug Administration (FDA)carried out an inspection on the company on 17 February 2014.
The FDA’s inspectionobserved that several batches of L-Citrulline were adulterated, as thestrength, purity and quality of the L-Citrulline samples fall below the its standardsas indicated on the L-Citrulline labels. The samples of L-Citrulline were then analysedand determined to be N-Acetyl-Leucine, a drug that was used for vertigotreatment. This analysis concluded that Medisca has violated the FDA Code ofFederal Regulations (CFR), 21 CFR §351(c),on the misrepresentation of strength. In addition, the FDA’sinspection observed that the labelling of the L-Citrulline was false andmisleading. Samples of API that were labelled as L-Citrulline were analysed anddetermined to be N-Acetyl-Leucine, hence concluded that Medisca has violatedthe 21 CFR §352(a) for false ormisleading label. Consequently, the usageof the adulterated and mislabelled L-Citrulline caused patients with UCD tosuffer from high levels of ammonia in their bodies, which resulted indevelopmental disabilities, brain damage, coma and death of the patients withUCD.
In response to theviolations, FDA has recommended healthcare providers to stop dispensingL-Citrulline from the 8 batches of adulterated L-Citrulline and to return allunused L-Citrulline stocks to Medisca. Patients were recommended to stop usingL-Citrulline from Medisca and direct any healthcare concerns to theirhealthcare professionals. The sale and usage of L-Citrulline Due to theviolations, Medisca received warning letters from the FDA about the adulteratedL-Citrulline and its misleading labels. Medisca then recalled and investigated 8batches of L-Citrulline and determined that none of the 8 batches containedL-Citrulline. Additionally, Medisca discovered the mix-up of L-Citrulline withN-Acetyl-Leucine was caused by the failure to verify the identity of productsMedisca purchased from a manufacturer.