PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 15, 2018 Initiated: July 24, 2018 #D-1044-2018

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.

Details

Recalling Firm
PharMEDium Services, LLC
Units Affected
450 Syringes
Distribution
Product was distributed throughout the United States
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by PharMEDium Services, LLC. Units affected: 450 Syringes.
Why was this product recalled?
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1044-2018.