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D-1085-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1085-2020 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: 210 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: 210 units

Product Description

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

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

193610002D, Exp 3/29/2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1085-2020
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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