Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 1,860 bags of Midazolam 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (such as loss of sterility assurance in a sterile injectable) are rated as Severe (4).
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 1,860 bags of Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) single-dose bags. The product is identified by NDC 4252-401-10 and 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 lots include Lot # 5/7/18 7482 40110P (BUD 9/4/2018), Lot # 5/22/18 0804 40110P (BUD 9/19/2018), and Lot # 5/3/18 1111 40110P (BUD 8/31/2018).
Healthcare providers and patients should discontinue use of the affected product and contact the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,860
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 (6)
- Lot # 5/7/18 7482 40110P
- BUD 9/4/2018
- 5/22/18 0804 40110P
- BUD 9/19/2018
- 5/3/18 1111 40110P
- BUD 8/31/2018.
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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