The Recall Desk
SevereFDA (Drugs)·D-0939-2018·Announced 2018-07-25

Avella Recalls Norepinephrine Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 4,280 bags of Norepinephrine 8 mg due to potential bag leakage and lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects (like bag leakage compromising sterility) align with a Severe rating, particularly given the critical nature of the drug.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 4,280 bags of NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL). The product is a single-dose bag with a concentration of 32 mcg/mL and a volume of 258 mL. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected product is distributed nationwide in the USA. Specific lot numbers and best-use dates are listed in the recall documentation, including lots with best-use dates ranging from June 22, 2018, to July 7, 2018.

Healthcare providers and patients should stop using the affected product and contact the manufacturer or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable
Hazard
Affected units
4,280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot #4/23/18 0101 81525P
  • 4/23/18 1020 81525P
  • BUD 6/22/2018
  • 4/30/18 1123 81525P
  • 4/30/18 1311 81525P
  • BUD 6/29/2018
  • 5/1/18 3456 81525P
  • BUD 6/30/2018
  • 5/8/18 3213 81525P
  • BUD 7/7/2018.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Related recalls

Same manufacturer · Avella of Deer Valley, Inc. Store 38

See all →

Same hazard · sterility

See all →