Agency classClass IIOur severity:Severe FDA (Drugs)·D-0955-2018·Announced 2018-07-25

Avella Recalls Midazolam Syringes Due to Potential Sterility Issues

Avella of Deer Valley, Inc. is recalling specific lots of Midazolam 1 mg/mL syringes due to a lack of assurance of sterility and potential bag leakage.

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 reports are rated as Severe (4). While specific injury reports are not detailed in the text, the classification and the nature of the hazard (sterility) align with the Severe criteria for drug recalls.

Plain-English summary

Avella of Deer Valley, Inc. is recalling specific lots of Midazolam 1 mg/mL single-dose syringes. The recall is due to a lack of assurance of sterility, which may be caused by potential leakage of the bags.

The affected product is identified by Lot #5/11/18 1050 28-40163M with a beyond-use date of July 25, 2018. The product was distributed nationwide in the USA and was intended for Methodist Willowbrook Hospital.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage

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 #:5/11/18 1050 28-40163M
BUD 7/25/2018.

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.

See all 38 products in this recall →

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

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Same hazard · sterility