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

D-1043-2018 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1043-2018 was initiated by PharMEDium Services, LLC on Jul 24, 2018 and is designated Class II. Reason for recall: CGMP deviations: Product was released while a hood certification discrepancy was being investigated. The recall status is terminated (terminated Dec 10, 2018). Affected quantity: 230 Intravia Bags.

Recall Details

Product Type: Drugs
Report Date: Aug 15, 2018
Initiation Date: Jul 24, 2018
Termination Date: Dec 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1043-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by PharMEDium Services, LLC

D-1091-2020 Class II — ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5… (Mar 16, 2020)
D-1081-2020 Class II — ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL… (Mar 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… (Mar 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… (Mar 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… (Mar 16, 2020)
D-1092-2020 Class II — fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For… (Mar 16, 2020)
D-1083-2020 Class II — rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use… (Mar 16, 2020)
D-1093-2020 Class II — fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe… (Mar 16, 2020)
D-1089-2020 Class II — fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500… (Mar 16, 2020)
D-1082-2020 Class II — nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP… (Mar 16, 2020)