Norepinephrine IV bags recalled for sterility validation deficiency
Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was 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 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 of injectable medication with incomplete sterilization validation. With no reported illnesses or injuries, the hazard is theoretical, meeting the rubric's criterion for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling norepinephrine 16 mg in dextrose 5% solution provided in 250 mL IV bags with a concentration of 64 mcg/mL. The recall affects 80 bags from lot 36-257069 with an expiration date of September 14, 2023. The affected product has NDC number 72196-8095-1 and was distributed nationwide.
The manufacturer initiated this recall due to lack of assurance of sterility. Validation data for the decontamination cycles used in the manufacturing process is lacking, which creates uncertainty about whether the product meets FDA sterility standards.
Healthcare facilities and providers should discontinue use of the affected lot immediately. Patients who have received this medication should consult their healthcare provider regarding potential exposure to the recalled product.
The recalled product
- Product
- norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Affected units
- 80
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: 36-257069
- Exp. 9/14/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, 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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