FDAFDA · Food and drugs·Recall number D-0424-2018
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Published February 21, 2018 · Recall initiated: February 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PharMEDium Services, LLC
- Distributor
- Product was distributed to SC, FL, NY, NY,WA
- Lot
- Lot #: 180080063D, Exp 4/9/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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