PHENYLephrine Intravenous Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling PHENYLephrine IV bags distributed nationwide. The company could not prove the products were properly sterilized.
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 involving an intravenous medication with no reported illnesses or injuries. However, it represents a risk-of-harm product where sterility failure could potentially cause serious infections. The recall is precautionary, based on lack of validation data rather than confirmed contamination.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling PHENYLephrine 10mg/250ml added to 0.9% sodium chloride IV bags (40mcg/mL concentration). Approximately 7,518 bags across multiple lot numbers with expiration dates from July through September 2023 are affected by this nationwide recall.
The recall was initiated because there is a lack of assurance of sterility. Specifically, the manufacturer did not provide sufficient validation data for the decontamination cycles used in the manufacturing process.
Healthcare facilities that have received these products should identify affected lot numbers and consult with their pharmacy director for guidance. Patients should discuss any concerns about their medications with their healthcare provider.
The recalled product
- Product
- PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous
- Hazard
- contamination-risk
- sterilization-failure
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 (20)
- Lot: 36-239333
- Exp. 7/11/2023
- 36-240005
- Exp. 7/13/2023
- 36-240800
- Exp. 7/17/2023
- 36-241139
- 36-241140
- Exp. 7/19/2023
- 36-241913
- Exp.7/23/2023
- 36-242557
- 36-242560
- Exp. 7/25/2023
- 36-244880
- 36-244883
- 36-244884
- 36-244885
- Exp. 8/1/2023
- 36-246717
Distribution
Distributed nationwide across the United States.
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