FDA Recalls Fentanyl Injection Solution for Underfilled Cassettes
OurPharma LLC is recalling 768 cassettes of FentaNYL Citrate injection solution due to underfilled units. The affected product was distributed in Illinois and Missouri.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall, the least serious category, with no reported illnesses or injuries. The underfilled cassettes represent a manufacturing quality defect affecting medication dosing, warranting a moderate score rather than low due to the involvement of a potent opioid medication.
Plain-English summary
OurPharma LLC is recalling FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution in 50mL cassettes. A total of 768 cassettes have been identified as part of this recall. The affected product is intended for intravenous use and bears NDC 73013-1001-01.
The recall was issued because the cassettes are underfilled, containing less than the labeled amount of medication. This manufacturing defect could result in patients receiving a smaller dose than prescribed.
The affected cassettes were distributed to healthcare facilities in Illinois and Missouri. The following lot numbers are included in this recall: Lot 100122080003 (Exp. 2/26/2023), Lot 100122090001 (Exp. 3/07/2023), and Lot 100122100002 (Exp. 4/05/2023).
Healthcare providers should immediately stop using these cassettes and verify inventory against the lot numbers listed. Patients who may have received medication from these cassettes should consult with their healthcare provider regarding their treatment.
The recalled product
- Product
- FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
- Manufacturer
- OurPharma LLC
- Category
- Drug — Injectable Medication
- Affected units
- 768
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 (6)
- Lots: 100122080003
- Exp. 2/26/2023
- 100122090001
- Exp. 3/07/2023
- 100122100002
- Exp. 4/05/2023
Distribution
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