Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 100 fentanyl syringes due to potential bag leakage and lack of sterility assurance.
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 and involves a lack of sterility assurance in a parenteral medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 100 single-dose syringes of fentaNYL 5 mcg Citrate, USP. The product was prepared for Cook Children's Medical Center by Advanced Pharma in Houston, Texas. The recall is limited to Lot # 5/24/18 0502 149-21072S with a beyond-use date of August 22, 2018.
The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. The agency has classified this recall as Class II.
Healthcare facilities and consumers who have this specific lot of fentanyl syringes should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 100
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 #: 5/24/18 0502 149-21072S
- BUD 8/22/2018.
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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