FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.
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 a Class II FDA recall of a parenteral medication due to lack of sterility assurance and missing decontamination validation data. The source does not report any illnesses or injuries associated with the product. The potential harm (contamination) is theoretical but significant for an injectable medication, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling phenylephrine 25 mg added to 0.9% sodium chloride in 250 mL intravenous (IV) bags nationwide. The recall was initiated because validation data for the decontamination cycles used in manufacturing is lacking, creating uncertainty about whether the product meets sterility requirements.
The affected lots are 36-249691, 36-249692 (expiration 8/20/2023), 36-250052, 36-250053 (expiration 8/22/2023), 36-251062 (expiration 8/24/2023), 36-251992 (expiration 8/30/2023), and 36-252467 (expiration 9/3/2023). A total of 1,853 IV bags have been distributed nationwide. The product was manufactured by Central Admixture Pharmacy Services, Inc. located at 2200 South 43rd Avenue, Phoenix, Arizona.
No illnesses or injuries have been reported in association with this product. For more information about this recall, patients and healthcare providers should contact the FDA or the manufacturer.
The recalled product
- Product
- phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 1,853
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 (12)
- Lot: 36-249691
- 36-249692
- Exp. 8/20/2023
- 36-250052
- 36-250053
- Exp. 8/22/2023
- 36-251062
- Exp. 8/24/2023
- 36-251992
- Exp. 8/30/2023
- 36-252467
- Exp. 9/3/2023
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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