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 potential presence of glass particulate matter.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 structural defect (glass particulates) in an injectable medication, which poses a significant risk of injury.
Plain-English summary
QuVa Pharma, Inc. is recalling specific lots of fentanyl 400 mcg/200 mL and ropivacaine HCl 0.1% 200 mg/200 mL in 0.9% Sodium Chloride 200 mL CADD, Preservative Free. The recall was initiated because the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particulates.
The affected product is distributed nationwide. The recall covers multiple lots with expiration dates ranging from November 2019 to January 2020. The specific lot numbers and expiration dates are listed in the structured product information.
Healthcare providers and patients should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as FDA Class II.
The recalled product
- Product
- fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
- 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 (20)
- Lots: 10029361 Exp. 11/15/2019
- 10029362 Exp. 11/15/2019
- 10029334 Exp. 11/14/2019
- 10029855 Exp. 11/19/2019
- 10029856 Exp. 11/19/2019
- 10030387 Exp. 11/25/2019
- 10030388 Exp. 11/25/2019
- 10031026 Exp. 12/12/2019
- 10031078 Exp. 12/12/2019
- 10031469 Exp. 12/16/2019
- 10031493 Exp. 12/16/2019
- 10031519 Exp. 12/17/2019
- 10031804 Exp. 12/23/2019
- 10031105 Exp. 12/12/2019
- 10031830 Exp. 12/23/2019
- 10031884 Exp. 12/24/2019
- 10032704 Exp. 1/8/2020
- 10032888 Exp. 1/12/2020
- 10032889 Exp. 1/12/2020
- 10032913 Exp. 1/13/2020
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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