Avella Recalls Phenylephrine Infusion Bags Due to Sterility Concerns
Avella of Deer Valley is recalling 300 bags of Phenylephrine 30 mg in NS 250 mL due to a lack of assurance of 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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 300 bags of Phenylephrine 30 mg added to NS 250 mL Bag. The product is prescription-only and was distributed nationwide in the United States. The specific lot number is 138-20180409@55, with an expiration date of 11/18/2018.
The recall was initiated because of a lack of assurance of sterility for the affected product. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions or replacement.
The recalled product
- Product
- Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Infusion Solution
- Affected units
- 300
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 (2)
- Lot# 138-20180409@55
- Exp 11/18/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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