QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.
What this means for you
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 potential glass particulate matter in an injectable medication, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
QuVa Pharma, Inc. is recalling fentanyl 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, a prescription medication, due to the potential presence of glass particulate matter. The recall was initiated after the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to this potential contamination.
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 provided by the FDA.
Healthcare providers and patients should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable Medication
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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