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D-1084-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1084-2020 was initiated by PharMEDium Services, LLC on Mar 16, 2020 and is designated Class II. Reason for recall: Firm is recalling 46 lots of various products because of a lack of sterility assurance. The recall status is terminated (terminated Feb 14, 2025). Affected quantity: 1840 units.

Recall Details

Product Type: Drugs
Report Date: Apr 15, 2020
Initiation Date: Mar 16, 2020
Termination Date: Feb 14, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1840 units

Product Description

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the US

Code Information

193510022D 3/17/2020 193510023D 3/17/2020 193580012D 3/25/2020 193600013D 3/26/2020 193640016D 3/30/2020 193530020D 3/19/2020 193540023D 3/22/2020 193540026D 3/22/2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1084-2020
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

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

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