FDA Recalls Fentanyl Citrate Injection Cassettes Due to Underfilling
OurPharma LLC is recalling 691 fentanyl citrate injection cassettes due to underfilled units. The recall affects lots distributed in Missouri with expiration dates between December 2022 and January 2023.
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 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The underfilled injection solution presents a dosing accuracy risk, but without documented harm, this meets the High severity criterion for risk-of-harm products with no reported injury.
Plain-English summary
OurPharma LLC recalled FentaNYL Citrate 2.5 mg/50 mL injection solution (NDC 73013-001-01) because some units were underfilled. The product is a single-use, preservative-free injection cassette intended for prescription use only.
A total of 691 cassettes were recalled. The affected lot numbers and their expiration dates are: 100122060007 (12/17/2022), 100122060008 (12/18/2022), and 100122070002 (01/09/2023). These cassettes were distributed in Missouri. OurPharma initiated the recall voluntarily on November 29, 2022.
The FDA classified this as a Class II recall based on the underfilling issue. The recall was terminated on September 20, 2024, indicating the manufacturer completed corrective actions and recall objectives were met.
The recalled product
- Product
- FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
- Manufacturer
- OurPharma LLC
- Category
- Drug — Injectable
- Affected units
- 691
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 (3)
- Lots: 100122060007 Exp. 12/17/2022
- 100122060008 Exp. 12/18/2022
- 100122070002 Exp. 01/09/2023.
Distribution
Distributed in 1 state:
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