Agency classClass IIOur severity:Severe FDA (Drugs)·D-0957-2018·Announced 2018-07-25

Avella Recalls Midazolam Syringes Due to Sterility Assurance Concerns

Avella of Deer Valley, Inc. is recalling 110 syringes of Midazolam 1 mg/mL 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious adverse health consequences such as infection.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 110 single-dose syringes of Midazolam 1 mg/mL (NDC 15082-401-76). The product is identified by Lot #5/14/18 2011 40176S and has a beyond-use date of September 11, 2018. The recall was initiated because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected product was distributed nationwide in the USA. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact Avella of Deer Valley, Inc. for further instructions or a return. This recall is limited to the specific lot and quantity identified in the notice.

The recalled product

Product: Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
infection
Affected units: 110

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 #:5/14/18 2011 40176S
BUD 9/11/2018.

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