FDA-Drug2020-04-15Class II

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

PharMEDium Services, LLC
Hazard

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Sold states
Distributed Nationwide in the US
Affected count
290 units
Manufactured in
36 Stults Rd, N/A, Dayton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2020

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