Avella Recalls Hydromorphone Injection Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 660 bags of Hydromorphone injection due to potential leakage that compromises 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile medical product where sterility is compromised is categorized as Severe (Score 4) due to the risk of infection or adverse health consequences.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 660 bags of HYDROmorphone 0.2mg/mL injection. The product is a 100 mL single-dose bag containing Hydromorphone HCL (USP) 20 mg and 0.9% Sodium Chloride (USP). The recall is being conducted 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 specific lots involved are identified by the codes 4/26/18 0520 22110P (Best Use Date 8/9/2018) and 5/14/18 1350 22110P (Best Use Date 8/27/2018). The NDC number for the product is 15082-221-10.
Healthcare providers and consumers should stop using the affected product and contact the recalling firm or their supplier for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable
- Affected units
- 660
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 (4)
- Lot #: 4/26/18 0520 22110P
- BUD 8/9/2018
- 5/14/18 1350 22110P
- BUD 8/27/2018.
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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