NORepinephrine IV Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling NORepinephrine 4 mg/250 mL IV bags due to lack of sterility assurance caused by insufficient validation of decontamination cycles. The affected lots were distributed nationwide.
What this means for you
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 an injectable medication for lack of sterility assurance. The hazard—potential microbial contamination from inadequate sterilization—presents a serious risk of harm, but no illnesses or injuries are reported in the source. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling NORepinephrine 4 mg/250 mL IV bags (NDC 72196-8097-1) due to lack of assurance of sterility. The recall stems from lacking validation data for the decontamination cycles used in manufacturing.
The affected product includes 1,187 IV bags containing NORepinephrine 4 mg/250 mL mixed with 0.9% sodium chloride (16 mcg/mL). The recalled lot numbers are 36-241043, 36-241044, 36-241045, and 36-241046, all expiring 7/18/2023. This product was distributed nationwide in the USA.
Patients and healthcare providers with this product should contact Central Admixture Pharmacy Services or the FDA for information on the recall and recommended next steps.
The recalled product
- Product
- NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Infusion
- Hazard
- sterility-failure
- contamination-risk
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 (5)
- Lot: 36-241043
- 36-241044
- 36-241045
- 36-241046
- Exp. 7/18/2023.
Distribution
Distributed nationwide across the United States.
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