Pharmedium Services, LLC

FDA Regulatory Profile

Summary

Total Recalls
291 (19 Class I)
510(k) Clearances
0
Inspections
19
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-1092-2020Class IIfentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMarch 16, 2020
D-1093-2020Class IIfentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PMarch 16, 2020
D-1082-2020Class IInICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syrinMarch 16, 2020
D-1090-2020Class IIePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, March 16, 2020
D-1091-2020Class IIePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV March 16, 2020
D-1081-2020Class IIePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use March 16, 2020
D-1086-2020Class IIsuccinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 9March 16, 2020
D-1087-2020Class IIrocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. DavisMarch 16, 2020
D-1089-2020Class IIfentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mMarch 16, 2020
D-1085-2020Class IIfentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride March 16, 2020
D-1083-2020Class IIrocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. DaviMarch 16, 2020
D-1084-2020Class IIHYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mMarch 16, 2020
D-1088-2020Class IIePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, PMarch 16, 2020
D-0627-2020Class IIINORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total VolumDecember 16, 2019
D-0625-2020Class IIINORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total VolumDecember 16, 2019
D-0626-2020Class IIINORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total VolumDecember 16, 2019
D-1488-2019Class IHydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N DJune 7, 2019
D-0374-2019Class II0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 peJanuary 2, 2019
D-0333-2019Class IIFentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, December 5, 2018
D-0334-2019Class IIFentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%,December 5, 2018