Avella Recalls Fentanyl Syringes Due to Sterility Assurance Concerns
Avella of Deer Valley is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL due to a 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility issues.
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe). The product is prescription-only and was distributed nationwide in the U.S.A. The specific lot affected is # 8/8/18 0200 15-21070S, with an expiration date of 11/06/2018.
The recall was initiated due to a lack of assurance of sterility. This classification indicates a potential risk that the product may not be sterile, which is a critical quality attribute for injectable medications.
Consumers and healthcare providers should discontinue use of the affected lot and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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 # 8/8/18 0200 15-21070S
- Exp 11/06/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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