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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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.
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