FDA-Drug2020-04-15Class II

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

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
210 units
Manufactured in
36 Stults Rd, N/A, Dayton, NJ, United States
Products
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2020

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