[04-11-2013] FDA is alerting healthcare providers who receive drugs from Shamrock Medical Solutions Group LLC (Shamrock) that these drugs may be mislabeled. The agency is advising healthcare providers to check medical supply stocks and remove all products from Shamrock in order to ensure these drugs are not administered to patients. This notice covers all drugs and dosage forms distributed by Shamrock including tablets, vials, ophthalmic and otic solutions and patches.
FDA’s recent inspection shows that Shamrock has been distributing drugs bearing incorrect labels. For example, Shamrock distributed drug labels that described (1) a different drug than what was included in the container, (2) a drug with the wrong dosage strength, and (3) a drug not identified as extended release.
Mislabeled drugs pose a serious risk to patients. Patients may receive a drug that causes harm resulting in unintended effects. The potential risks include overdose, dangerous drug interactions, and unnecessary exposure to toxicity and side effects. Most importantly, patients would not receive the therapeutic benefits from the drug they need to take. In addition, patients may experience the side effects of a drug they do not need.
Shamrock repackages and relabels drugs for many hospitals, pharmacies and medical centers nationwide. FDA has previously sent warning letters to Shamrock for violating the current good manufacturing practice (CGMP) and distributing incorrectly labeled drugs.
Adverse reactions or quality problems experienced with the use of these drugs may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178