PlainRecalls
FDA Drug Moderate Class II Terminated

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

Reported: July 25, 2018 Initiated: June 12, 2018 #D-0930-2018

Product Description

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Details

Units Affected
5400 syringes
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 5400 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-0930-2018.