PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 15, 2020 Initiated: March 16, 2020 #D-1082-2020

Product Description

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

Reason for Recall

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

Details

Recalling Firm
PharMEDium Services, LLC
Units Affected
80 units
Distribution
Distributed Nationwide in the US
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by PharMEDium Services, LLC. Units affected: 80 units.
Why was this product recalled?
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2020. Severity: Moderate. Recall number: D-1082-2020.