PlainRecalls
FDA Drug Moderate Class II Terminated

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

Reported: July 25, 2018 Initiated: June 12, 2018 #D-0959-2018

Product Description

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Details

Units Affected
850 syringes
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 850 syringes.
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-0959-2018.