Avella Recalls Phenylephrine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 40 bags of Phenylephrine 10 mg due to potential leakage that compromises sterility. The product was distributed nationwide.
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. Per the rubric, an FDA Class II recall involving a significant risk of harm (loss of sterility in an injectable medication) is rated as Severe.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 40 single-dose bags of Phenylephrine 10 mg (NDC 15082-856-25). The recall is due to a lack of assurance of sterility caused by potential leakage of the bags. The affected lot number is 4/30/18 0732 558-85625P, with a beyond-use date of 6/29/2018.
The product was prepared for Redlands Community Hospital Pharmacy by Advanced Pharma and distributed nationwide in the USA. The bags contain Phenylephrine HCL (USP) 10mg and 0.9% Sodium Chloride (USP) 250 mL.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Medication
- Affected units
- 40
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 #: 4/30/18 0732 558-85625P
- BUD 6/29/2018 .
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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