PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 15, 2020 Initiated: March 16, 2020 #D-1081-2020

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.

Details

Recalling Firm
PharMEDium Services, LLC
Units Affected
1075 units
Distribution
Distributed Nationwide in the US
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by PharMEDium Services, LLC. Units affected: 1075 units.
Why was this product recalled?
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2020. Severity: Moderate. Recall number: D-1081-2020.