BETHESDA, MD 12 Apr 2013—Without mentioning the word recall, FDA on Thursday posted a notice advising pharmacies and other customers of Shamrock Medical Solutions Group LLC to take action to ensure drug products from that company are not administered to patients.
The agency said these products "may be mislabeled."
Shamrock Medical describes itself as an FDA-registered drug repackager that is licensed in more than 20 states.
FDA said its recent inspection of a Shamrock Medical facility revealed that drug products bore incorrect labels. The labels on containers did not always identify the actual contents.
According to FDA, the company repackages and relabels drug products for 91 hospitals, pharmacies, and medical centers.
The agency said its notice applies to all drugs and dosage forms that Shamrock Medical has distributed.