Agency classClass IIOur severity:Severe FDA (Drugs)·D-0956-2018·Announced 2018-07-25

Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 220 bags of Midazolam 0.5mg/mL due to potential bag leakage and 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 220 single-dose bags of Midazolam 0.5mg/mL (100 mL). The product 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.

The affected product is identified by NDC 15082-408-10. Specific lot numbers and best use dates are listed in the recall documentation. The product was prepared for Coral Gables Hospital by Advanced Pharma.

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

The recalled product

Product: Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 220

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 (8)

Lot #:5/21/18 0506 240-40810P
BUD 8/4/2018
5/22/18 0501 86-40810P
BUD 8/5/2018
5/25/18 0900 410-40810P
BUD 8/8/2018
6/6/18 0836 86-40810P
BUD 8/20/2018.

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