FDA-Drug2020-04-15Class II

nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01

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
80 units
Manufactured in
36 Stults Rd, N/A, Dayton, NJ, United States
Products
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2020

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