QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 550 mcg/55 mL syringes due to the presence of glass particulate matter.
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, particularly given the risk of injury from glass particulate matter in an injectable medication.
Plain-English summary
QuVa Pharma, Inc. is recalling fentanyl 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free. The recall was initiated because of the presence of particulate matter, specifically due to the potential for glass particles in the product.
The affected product is identified by NDC 70092-1274-50, Lot 10031855, with an expiration date of 12/24/2019. The recall is distributed nationwide.
Healthcare providers and patients should stop using the affected syringes and contact QuVa Pharma or their local FDA office for further instructions.
The recalled product
- Product
- fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable
- Hazard
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 (1)
- Lot: 10031855 Exp. 12/24/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by QuVa Pharma, Inc. 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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