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D-1091-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1091-2020 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: 900 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: 900 units

Product Description

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

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

193520006D 3/18/2020 193530009D 3/19/2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1091-2020
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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