Epinephrine IV Bags Recalled Due to Unvalidated Sterility Process
Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.
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: FDA Class II recall of an injectable medication with unvalidated sterility assurance procedures. Although no illnesses or injuries are reported, this is a high-risk product category where sterility deficiencies pose serious potential harm. Score 3 applies as a risk-of-harm product without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 333 units of EPINEPHrine 2 mg in dextrose 5% 250 mL IV bags (8 mcg/mL concentration, NDC 72196-6030-1). The affected lot is 36-251702, which expires August 29, 2023.
The recall was issued because the manufacturer lacks validation data for decontamination cycles used in the preparation process. This creates insufficient assurance of product sterility, which is a critical requirement for injectable medications.
The affected product was distributed nationwide in the United States.
Healthcare providers and facilities should immediately stop using the affected lot and contact Central Admixture Pharmacy Services, Inc. (located at 2200 South 43rd Avenue, Phoenix, AZ 85043) or the FDA for guidance on proper handling and return procedures.
The recalled product
- Product
- EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Hazard
- sterility-assurance
- 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 (2)
- Lot: 36-251702
- Exp. 8/29/2023
Distribution
Distributed nationwide across the United States.
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