Home / Recalls / PharMEDium Services, LLC / D-1043-2018

D-1043-2018 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
July 24, 2018
Termination Date
December 10, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
230 Intravia Bags

Product Description

10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.

Reason for Recall

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

Distribution Pattern

Product was distributed throughout the United States

Code Information

Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018

Other recalls by PharMEDium Services, LLC

  • D-1081-2020 Class II — ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL (March 16, 2020)
  • D-1082-2020 Class II — nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 1 (March 16, 2020)
  • D-1086-2020 Class II — succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For (March 16, 2020)
  • D-1084-2020 Class II — HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 (March 16, 2020)
  • D-1092-2020 Class II — fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For I (March 16, 2020)
  • D-1089-2020 Class II — fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 (March 16, 2020)
  • D-1091-2020 Class II — ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 (March 16, 2020)
  • D-1088-2020 Class II — ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL sy (March 16, 2020)
  • D-1085-2020 Class II — fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, (March 16, 2020)
  • D-1090-2020 Class II — ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD S (March 16, 2020)