PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

Reported: July 25, 2018 Initiated: June 12, 2018 #D-0935-2018

Product Description

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Details

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

Frequently Asked Questions

What product was recalled?
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 275 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-0935-2018.