PlainRecalls
FDA Drug Moderate Class II Terminated

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

Reported: July 25, 2018 Initiated: June 12, 2018 #D-0940-2018

Product Description

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Details

Units Affected
200 bags
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 200 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0940-2018.