D-1081-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1081-2020 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: 1075 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
1075 units

Product Description

ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12

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

193500004D 3/16/2020 193510006D 3/17/2020 193530011D 3/19/2020 193570003D 3/23/2020

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1081-2020
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.

Source: openFDA record for D-1081-2020. Report a data issue: hello@regdatalab.com.