Class II
Terminated
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
This recall has been terminated (originally issued February 21, 2018).
- 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
- Official Source
- View on FDA website ↗
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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