Avella Recalls Norepinephrine Bags Due to Potential Leakage
Avella of Deer Valley is recalling 1,290 bags of Norepinephrine Bitartrate 4 mg due to potential leakage and lack of sterility assurance.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, such as loss of sterility in IV products.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 1,290 single-dose bags of Norepinephrine Bitartrate (USP) 4 mg in 0.9% Sodium Chloride (USP). The product is identified by NDC 42852-860-25 and was distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. The affected lots are 5/14/18 1330 86025P with a best use date of 7/8/2018, and 5/24/18 2314 86025P with a best use date of 7/18/2018.
Healthcare providers and patients should discontinue use of the affected product and contact Avella of Deer Valley, Inc. for further instructions or replacement.
The recalled product
- Product
- NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — IV Infusion
- Hazard
- Affected units
- 1,290
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 (4)
- Lot #: 5/14/18 1330 86025P
- BUD 7/8/2018
- 5/24/18 2314 86025P
- BUD 7/18/2018. .
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.
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