Avella Recalls Norepinephrine Syringes Due to Potential Sterility Compromise
Avella of Deer Valley, Inc. is recalling 850 single-dose norepinephrine syringes nationwide due to potential bag leakage that may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 rating under the rubric for potential serious temporary or medically reversible health consequences.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 850 single-dose syringes of NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. The product is identified by NDC 42852-807-61 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. This defect could allow contamination of the sterile solution.
Healthcare providers and patients should stop using the affected syringes and contact Avella of Deer Valley, Inc. for further instructions. The affected lots include those with expiration dates of 6/21/2018, 6/23/2018, and 7/15/2018.
The recalled product
- Product
- NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Medication
- Affected units
- 850
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 (6)
- Lot #: 5/7/18 0301 2-80761S
- BUD 6/21/2018
- 5/9/18 0510 2-80761S
- BUD 6/23/2018
- 5/21/18 1807 80761S
- BUD 7/15/2018.
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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