QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Glass Particulates
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulates.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (glass particulates in an injectable) are classified as Severe (Score 4), as they are not Class I but involve a risk of harm beyond minor labeling errors.
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 bags. 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 a prescription medication 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.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the 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 bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable
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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