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D-1044-2018 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1044-2018 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: 450 Syringes.

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: 450 Syringes

Product Description

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, 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 181730039D, Exp 09/20/2018

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1044-2018
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.

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