Notice to Pharmacies in the Philadelphia Area
FDA warns pharmacies of a potentially counterfeit drug purchased from a suspended pharmacy in Philadelphia.
[10-17-2017] The U.S. Food and Drug Administration is alerting pharmacies in the Philadelphia region to check any inventory they purchased from 52nd Street Pharmacy since January 1, 2017. FDA is concerned that 52nd Street Pharmacy may have sold counterfeit prescription drugs to other pharmacies in the region.Currently, FDA only has information that 52nd Street Pharmacy may have sold a bottle of Harvoni (ledipasvir/sofosbuvir), a hepatitis C drug, to another local pharmacy that contained the wrong medication.
FDA is providing this warning because 52nd Street Pharmacy may have sold other drug products that do not contain the medication that was supposed to be in the bottle.
There is no indication that Gilead’s FDA-approved Harvoni is at risk, and FDA believes that the authentic product remains safe and effective for its intended use. Patients should be advised to continue taking Harvoni as prescribed.
The potentially counterfeit Harvoni product can be identified by the following:
* Packaging includes the lot number 006170 with an expiration date of 12/2017.
* Tablets are orange, oblong-shaped, and have a “C” on one side of the tablet with no imprint on the other side.
FDA requests pharmacies and health care professionals report suspect products to FDA’s Office of Criminal Investigations. FDA is not aware of any adverse events associated with this event. The agency is committed to protecting public health by helping to secure the drug supply chain against counterfeit and substandard medications that enter the U.S. supply chain.
