FDAFDA · Food and drugs·Recall number D-1089-2020
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Published April 15, 2020 · Recall initiated: March 16, 2020
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
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PharMEDium Services, LLC
- Distributor
- Distributed Nationwide in the US
- Lot
- 193510008D 3/17/2020 193580004D 3/25/020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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