QuVa Pharma Recalls Fentanyl Injection Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 100 mcg/2 mL injections because of potential glass particulate matter. The recall covers specific lots distributed nationwide.
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. The presence of glass particulate matter in an injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
QuVa Pharma, Inc. is recalling fentanyl 100 mcg/2 mL (50 mcg/mL) Preservative Free injections. The recall was initiated because the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential presence of glass particulate matter.
The affected product is identified by NDC 70092-1097-43. The recall includes specific lots with expiration dates ranging from November 17, 2019, to December 30, 2019. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
- 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 (10)
- Lots: 10029772 Exp. 11/17/2019
- 10030627 Exp. 11/22/2019
- 10030626 Exp. 11/21/2019
- 10030408 Exp. 11/25/2019
- 10030512 Exp. 11/27/2019
- 10031107 Exp. 12/5/2019
- 10031268 Exp. 12/10/2019
- 10031437 Exp. 12/15/2019
- 10031821 Exp. 12/23/2019
- 10032285 Exp. 12/30/2019
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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