PharMEDium Services, LLC recalls 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Recalled February 21, 2018 · FDA recall D-0424-2018 · PharMEDium Services
Hazard
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin. · FDA Class II
Units
500 syringes
Sold at
Product was distributed to SC, FL, NY, NY,WA
Description
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Product
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Manufacturer(s)
PharMEDium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →