The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0134-2019·Announced 2018-11-07

Avella Recalls Phenylephrine Bags Due to Sterility Concerns

Avella of Deer Valley is recalling 300 bags of Phenylephrine 25 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the agency's Class II classification for a sterile drug product involving sterility assurance issues aligns with the Severe criteria for significant potential harm.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 300 bags of Phenylephrine 25 mg added to NS 250 mL Bag, Rx only. The product was manufactured by Avella of Deer Valley, Inc. Store 38 and distributed nationwide in the U.S.A.

The recall was initiated because of a lack of assurance of sterility. The affected product is identified by Lot# 138-20182308@88 and has an expiration date of 11/06/2018.

Healthcare providers and patients should discontinue use of the recalled product. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Phenylephrine 25 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 — IV Infusion
Hazard
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# 138-20182308@88
  • Exp 11/06/2018

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.

See all 5 products in this recall →

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

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