FDA recall D-1088-2020

Product

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

Reason for recall

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

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-04-15

Termination date

2025-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1088-2020