QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.
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 involves a high-risk medication (fentanyl) and a physical hazard (glass particulates) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
QuVa Pharma, Inc. is recalling specific lots of fentanyl 200 mcg/100 mL and ropivacaine HCl 0.2% in 0.9% sodium chloride 100 mL CADD infusions. The recall was initiated because of the presence of particulate matter in the product.
The manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particles. The affected lots were distributed nationwide. The recall covers multiple lot numbers with expiration dates ranging from November 2019 to January 2020.
Healthcare providers and patients should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable Infusion
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 (20)
- Lots: 10029829 Exp. 11/18/2019
- 10029883 Exp. 11/19/2019
- 10029829 Exp. 11/18/2019
- 10030056 Exp. 11/24/2019
- 10030867 Exp. 11/27/2019
- 10031005 Exp. 12/4/2019
- 10030950 Exp. 12/3/2019
- 10031103 Exp. 12/6/2019
- 10031006 Exp. 12/4/2019
- 10031142 Exp. 12/8/2019
- 10031274 Exp. 12/10/2019
- 10031710 Exp. 12/12/2019
- 10031628 Exp. 12/19/2019
- 10031777 Exp. 12/22/2019
- 10031683 Exp. 12/22/2019
- 10032050 Exp. 12/29/2019
- 10032051 Exp. 12/29/2019
- 10032435 Exp. 1/2/2020
- 10032468 Exp. 1/2/2020
- 10032545 Exp. 1/5/2020
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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