PlainRecalls
FDA Drug Moderate Class II Terminated

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

Reported: July 25, 2018 Initiated: June 12, 2018 #D-0963-2018

Product Description

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Details

Units Affected
10500 syringes
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 10500 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-0963-2018.