Drug product

100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC

D-0424-2018

February 05, 2018

Class II

Product summary

Firm: PharMEDium Services, LLC
Event: Event 79063
Status: Terminated
Classification: Class II
Quantity: 500 syringes
Official record key: drug-enforcement:D-0424-2018

Official wording

Reason: 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.

Code information: Lot #: 180080063D, Exp 4/9/18

Distribution pattern: Product was distributed to SC, FL, NY, NY,WA

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

out of specification
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of assurance of sterility