QuVa Pharma Recalls Subpotent Norepinephrine IV Bags Nationwide
QuVa Pharma is recalling 528 bags of Norepinephrine 4 mg in 5% Dextrose because the active ingredient may be missing. The product was distributed to hospitals nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.
Plain-English summary
QuVa Pharma, Inc. is recalling 528 bags of Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free. The product is prescription-only and was distributed nationwide to hospitals in the USA. The specific lot number is 30000271, with an expiration date of 10/1/18.
The recall was initiated because the product is subpotent, meaning the active ingredient may not be present in the bag. This defect could result in patients not receiving the intended therapeutic effect of the medication.
Hospitals and healthcare facilities should stop using the affected product and contact QuVa Pharma for further instructions. Patients who have received this specific lot should consult their healthcare provider regarding their treatment.
The recalled product
- Product
- Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — IV Infusion
- Affected units
- 528
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 (2)
- Lot #:30000271
- Exp 10/1/18
Distribution
Distributed nationwide across the United States.
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