RecallDepth
Class II Terminated

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

Company
Pharmedium Services, Llc
Recall Initiated
February 5, 2018
Posted
February 21, 2018
Recall Number
D-0424-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
500 syringes
Firm Location
Dayton, NJ, United States

Reason for Recall

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.

Distribution

Product was distributed to SC, FL, NY, NY,WA

Lot / Code Info

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

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