QuVa Pharma Recalls Fentanyl Bags Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl 2500 mcg/50 mL bags nationwide due to the presence of glass particulate matter.
What this means for you
Illness, injury, or structural failure has been reported. 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 particulate matter) in an injectable drug, which poses a significant risk of injury.
Plain-English summary
QuVa Pharma, Inc. is recalling fentanyl 2500 mcg/50 mL (50 mcg/mL) 50 mL bags, preservative free, prescription only. The recall affects lots 10030890, 10031264, 10031093, and 10032337, which have expiration dates ranging from December 2, 2019, to December 31, 2019. The product was distributed nationwide.
The recall was initiated because of the presence of particulate matter, specifically due to the potential for glass particles in the fentanyl active pharmaceutical ingredient (API). The FDA has classified this recall as Class II.
Healthcare providers and patients should discontinue use of the affected lots and contact QuVa Pharma for further instructions or replacements.
The recalled product
- Product
- fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
- 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 (4)
- Lots: 10030890 Exp. 12/2/2019
- 10031264 Exp. 12/10/2019
- 10031093 Exp. 12/6/2019
- 10032337 Exp. 12/31/2019
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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