QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter (glass) in an injectable medication, which poses a risk of harm even without reported injuries.
Plain-English summary
QuVa Pharma, Inc. is recalling fentanyl 250 mcg/5 mL (50 mcg/mL) 5 mL syringes, preservative-free, prescription only. 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 70092-1098-44. The recall includes specific lots with expiration dates ranging from November 2019 to December 2019. The distribution pattern for these products is nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the supplier or the manufacturer as directed by the recall firm.
The recalled product
- Product
- fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable
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)
- Lots: 10030458 Exp. 11/26/2019
- 10031113 Exp. 12/5/2019
- 10031305 Exp. 12/11/2019
- 10031417 Exp. 12/15/2019
- 10031765 Exp. 12/26/2019
- 10032259 Exp. 12/30/2019
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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