Home / Recalls / PharMEDium Services, LLC / D-0424-2018

D-0424-2018 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-0424-2018 was initiated by PharMEDium Services, LLC on Feb 5, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 24, 2018). Affected quantity: 500 syringes.

Recall Details

Product Type: Drugs
Report Date: Feb 21, 2018
Initiation Date: Feb 5, 2018
Termination Date: Apr 24, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 500 syringes

Product Description

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

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 Pattern

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

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0424-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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