Compounded Phenylephrine Solution Recalled Due to Wrong Base Diluent
Advanced Compounding Solutions is recalling a compounded phenylephrine solution made with 5% Dextrose instead of the correct 0.9% Sodium Chloride diluent. The error affects 198 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III FDA recall with no reported illnesses or injuries. Although the incorrect diluent represents a manufacturing error with potential patient-safety implications, the FDA's Class III classification—reserved for situations with no direct adverse health impact—supports a Moderate severity rating.
Plain-English summary
Advanced Compounding Solutions is recalling Phenylephrine HCl 20 mg in 250mL bags (NDC 71546-451-25, Lot #20230323-728BF8) distributed nationwide in the United States. The product was compounded using 5% Dextrose as the base solution instead of the specified 0.9% Sodium Chloride.
The use of an incorrect diluent in a compounded medication represents a manufacturing error that could affect the delivery and efficacy of the drug. This recall affects 198 units with an expiration date of August 2023.
Healthcare providers and patients with this product should discontinue use immediately and contact Advanced Compounding Solutions or their healthcare provider for guidance on appropriate replacement therapy.
The recalled product
- Product
- Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
- Manufacturer
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Hazard
- compounding-error
- wrong-diluent
- medication-mix-up
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 # 20230323-728BF8
- exp. 08/20/2023
Distribution
Distributed nationwide across the United States.
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